MEDEVICE™ helps medical device, combination product, and pharmaceutical companies eliminate regulatory bottlenecks, avoid costly submission delays, and reach FDA clearance or approval faster — with a clear, de-risked pathway from day one.
If any of these are holding up your timeline, you're not alone — and they're exactly what we specialize in solving.
Your 510(k) or PMA was bounced back before review even started — costing you weeks or months of lost time.
Additional Information (AI) requests and clinical hold concerns are pushing your timeline further out with no clear resolution path.
Unclear which FDA center has jurisdiction, how to file an RFD, or how to satisfy both drug and device requirements simultaneously.
Gaps in design controls or traceability discovered too late — right when you need to submit or face an FDA inspection.
An FDA inspection uncovered quality system gaps, and you need an expert-led response and remediation plan — fast.
Not sure if your product needs a 510(k), De Novo, PMA, or combination product designation? Picking the wrong pathway can cost months.
We partner with medical device and pharmaceutical organizations at every stage of the product lifecycle, delivering specialized consulting across quality, regulatory, engineering, and clinical disciplines.
Expert FDA 510(k), PMA, De Novo, IND, and NDA strategy and submission support. Navigating complex regulatory pathways with precision and speed.
Find Your Regulatory Pathway →ISO 13485, 21 CFR Part 820, and EU MDR compliant QMS design, implementation, gap assessments, and audit preparation for sustainable compliance.
Find Your Regulatory Pathway →IND applications, clinical trial protocol development, FDA meeting preparation, and combination product regulatory strategy for drugs and devices.
Find Your Regulatory Pathway →NIH SBIR/STTR, NSF, BARDA, and state funding grant writing with deep regulatory and scientific expertise to maximize award potential.
Find Your Regulatory Pathway →MEDEVICE™ is a specialized regulatory and quality consulting firm dedicated exclusively to medical devices, pharmaceuticals, and combination products. Our consultants average 15+ years of industry experience spanning FDA, design controls, clinical operations, and contract manufacturing.
From startup ventures seeking their first 510(k) clearance to Fortune 500 companies managing global regulatory portfolios, we deliver the expert guidance that moves products through the regulatory pathway efficiently.
Learn About UsA practical, 40-point checklist covering regulatory strategy, design controls, risk management, quality systems, and submission readiness — built by former FDA reviewers and industry regulatory leaders. Find out exactly where your product stands before you submit.
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Deep discovery of your regulatory goals, current state, product classification, and submission pathway requirements.
Tailored regulatory roadmap, timeline, and resource plan aligned to your submission type, target markets, and risk profile.
Expert consultants embedded in your team, authoring submissions, remediating DHFs, and managing FDA correspondence.
Post-market surveillance support, corrective actions, re-submissions, and ongoing regulatory maintenance programs.
Trusted by medical device companies, pharmaceutical firms, and combination product manufacturers worldwide.
"MEDEVICE™ guided our 510(k) submission from gap assessment through clearance in record time. Their FDA expertise and hands-on approach made what seemed impossible feel straightforward."
"Their combination product regulatory strategy was exactly what we needed. Deep knowledge of 21 CFR Part 3 designation requests and FDA intercenter agreements — outstanding consultants."
"The DHF remediation project was completed on time and on budget. Our QMS now fully meets ISO 13485 and FDA requirements. Highly recommend MEDEVICE™ for any quality work."
Start with a free FDA Strategy Assessment — we'll review your product, identify the fastest compliant pathway, and flag risks before they cost you time.
Get Your FDA Strategy AssessmentMEDEVICE™ was founded by a team of former FDA reviewers, industry quality directors, and biomedical engineers who recognized a critical gap: companies developing life-saving products needed regulatory partners with true depth — not generalists.
Today we serve startup companies seeking their first clearance alongside multinational corporations managing complex global regulatory portfolios across the FDA, EU MDR, Health Canada, TGA, and other regulatory bodies.
Our consultants maintain current knowledge of evolving FDA guidance, ICH guidelines, ISO standards, and emerging regulatory policy — so your submissions are always current and complete.
To help medical device and pharmaceutical innovators bring safe, effective products to market through expert regulatory strategy, quality assurance, and clinical consulting.
To be the most trusted regulatory consulting partner in the industry — known for technical excellence, integrity, and genuine commitment to patient safety outcomes.
We provide honest, evidence-based guidance even when it's not what clients want to hear. Regulatory compliance cannot be shortcut, and we won't pretend otherwise.
Regulatory affairs and quality management expert with deep expertise in FDA 510(k), PMA, IND/NDA submissions, combination products, design controls, DHF remediation, ISO 13485 QMS implementation, and NIH SBIR/STTR grant writing. Dedicated to helping medical device and pharmaceutical companies bring safe, effective products to market.
Discuss your regulatory challenges with consultants who have been there before.
Get Your FDA Strategy AssessmentWe offer on-demand, scalable consulting solutions tailored to your specific needs. MEDEVICE™ consultants integrate seamlessly into your team at any point in the project and manage small to complex Statement of Work (SOW) engagements — whether you need us to join your team directly or manage deliverables and workstreams independently so you don't have to worry about it. Our consultants bring hands-on expertise in FDA regulatory strategy, quality systems, clinical development, and engineering design across the following areas:
Expert regulatory strategy and submissions for drug-device, biologic-device, and drug-biologic combination products under 21 CFR Part 3 and Part 4. Services include Request for Designation (RFD) filings, intercenter consultation management, CDER/CDRH primary mode of action analysis, and fully integrated combination product submissions that satisfy both drug and device regulatory requirements.
Comprehensive design control program development and implementation aligned to 21 CFR Part 820 Subpart C and ISO 13485 Section 7.3. We develop design plans, define user needs and design inputs, create design outputs, establish design review protocols, author verification and validation plans, and build complete Design History Files (DHF) that satisfy FDA and EU MDR technical documentation requirements.
Full ISO 14971:2019 risk management file development for medical devices and combination products. Our risk management services encompass hazard identification and analysis, probability and severity estimation, risk control measure selection, FMEA/FMECA, risk-benefit analysis, residual risk evaluation, and post-market risk management updates. We integrate risk management deliverables directly into design control and regulatory submission packages.
Engineering design and product development consulting for medical devices from concept through design transfer. We support feasibility assessments, design for manufacturability (DFM), material selection, biocompatibility planning per ISO 10993, bench testing, prototype development, and V&V protocol authoring. Our engineers bridge the gap between product innovation and regulatory compliance to keep development on schedule and on budget.
Dedicated regulatory project management for FDA submissions, QMS implementations, product development programs, and remediation projects. We establish project scope, timelines, resource plans, and milestone tracking — coordinating cross-functional teams, managing FDA correspondence timelines, and ensuring regulatory deliverables are completed on schedule. Our PMs bring deep domain knowledge, not just scheduling tools.
End-to-end quality assurance consulting for medical device manufacturers under ISO 13485:2016, 21 CFR Part 820 (QMSR), and EU MDR 2017/745. Services include QMS gap assessments, SOP and work instruction development, CAPA program design, complaint handling systems, supplier quality management, internal audit programs, management review facilitation, and FDA inspection readiness preparation and mock audits.
Comprehensive FDA regulatory affairs consulting spanning the full device and drug regulatory pathway. We provide 510(k) premarket notification preparation and management, PMA application development, De Novo classification requests, IND/NDA/BLA submissions, pre-submission (Q-Sub) meeting facilitation, FDA correspondence authoring, Breakthrough Device designation requests, and post-market regulatory maintenance. International regulatory strategy covering EU MDR, Health Canada, TGA, and PMDA also available.
Human factors engineering (HFE) and usability engineering consulting aligned to FDA's guidance on applying human factors to medical devices and IEC 62366-1:2015. We conduct use-related risk analysis, design formative and summative usability studies, author HFE/UE reports, support user interface design decisions, and prepare complete HFE documentation packages for 510(k) and PMA submissions — including for combination products requiring human factors data.
Systematic Design History File remediation to bring legacy medical device products into full compliance with 21 CFR Part 820 design control requirements and EU MDR Annex II technical documentation standards. We assess existing DHF completeness, identify gaps, reconstruct missing design control deliverables, establish traceability matrices linking user needs through validation evidence, and create audit-ready DHF packages that satisfy FDA investigators and Notified Body reviewers.
Professional grant writing services for NIH SBIR/STTR Phase I and Phase II applications, NSF SBIR, BARDA, DoD SBIR, and state-level funding programs. Our grant writers bring both scientific rigor and regulatory expertise — crafting compelling Specific Aims, Innovation, Approach, and Commercialization Plan sections that resonate with study sections. We also support budget development, letters of support coordination, and resubmission strategy following reviewer feedback.
Biostatistics and clinical data analysis consulting for medical device and pharmaceutical regulatory submissions. Services include statistical analysis plan (SAP) development, sample size and power calculations, clinical performance study design, equivalence and non-inferiority analysis, real-world evidence analysis, and statistical sections for 510(k), PMA, IDE, and NDA submissions. We ensure statistical methodology meets FDA and ICH E9 guidance requirements.
Dedicated regulatory and quality consulting for startup and early-stage medical device and pharmaceutical companies. We help founders and early teams establish the right regulatory strategy from day one — including product classification, regulatory pathway selection, QMS framework design, investor-ready regulatory summaries, pre-submission meeting strategy, and first FDA submission preparation. Our startup consulting is structured to scale with your company as you grow from concept to cleared product.
Our consultants maintain deep expertise across the standards that govern medical devices globally.
Tell us about your product and get a free FDA Strategy Assessment — we'll map the fastest compliant path to market.
Get Your FDA Strategy AssessmentTo help our clients reach their goals, MEDEVICE™ offers specific integrated solutions. For most of our integrated programs, we put together a unique team of qualified resources and a detailed scope of work to ensure your needs are fully met or exceeded. Our integrated solutions combine regulatory strategy, quality systems, and engineering expertise into coordinated programs that deliver complete results — not piecemeal deliverables — across the following areas:
A fully integrated, end-to-end program for companies developing drug-device or biologic-device combination products. We manage the entire regulatory and quality lifecycle: combination product classification and RFD filings, constituent part regulatory strategies for both the device and drug/biologic components, integrated submission authoring across CDER and CDRH, design controls, risk management, human factors, and post-market compliance — all coordinated by a single MEDEVICE™ program team accountable for on-time, complete delivery.
A structured, program-managed Design History File remediation engagement for medical device manufacturers with legacy products that lack complete or compliant design control documentation. Our team conducts a thorough DHF gap assessment, develops a remediation roadmap, and systematically reconstructs missing design control deliverables — user needs, design inputs and outputs, verification and validation protocols and reports, design review records, and traceability matrices — producing an audit-ready DHF that satisfies both FDA investigators and EU MDR Notified Body requirements.
Complete quality management system design and implementation for medical device manufacturers who need an ISO 13485:2016 and 21 CFR Part 820 (QMSR) compliant QMS built from the ground up or substantially updated. Our integrated program covers QMS scoping and design, procedure and work instruction authoring, electronic QMS (eQMS) configuration support, employee training program development, supplier qualification frameworks, CAPA and complaint systems, internal audit programs, and management review processes — delivering a fully documented, inspection-ready quality system.
Comprehensive product development program spanning concept through design transfer and first FDA submission. MEDEVICE™ provides an integrated team covering regulatory strategy, design controls, risk management, engineering design support, biocompatibility planning, V&V execution oversight, human factors studies, and submission authoring — all coordinated under a single project manager. This program is designed for companies that need to move fast without sacrificing the regulatory rigor required for FDA clearance or approval.
A fully embedded outsourced regulatory and quality function for medical device and pharmaceutical companies that do not have in-house regulatory expertise or need to augment existing teams on a sustained basis. Under this retainer-based partnership model, MEDEVICE™ serves as your dedicated regulatory affairs and quality team — handling FDA correspondence, managing submission timelines, responding to agency inquiries, maintaining your QMS, supporting product changes through regulatory review, and providing strategic regulatory counsel on an ongoing basis. Scalable engagement levels available from part-time support to a full embedded team.
Fragmented consulting — different vendors for regulatory, quality, and engineering — creates gaps, miscommunications, and delays. MEDEVICE™ integrated programs eliminate that risk by delivering a coordinated, single-source solution under unified accountability.
Our cross-functional teams include regulatory strategists, quality engineers, biostatisticians, and clinical specialists working together from day one — so nothing falls through the cracks.
Let's discuss how an integrated program can accelerate your path to market — start with a free FDA Strategy Assessment.
Get Your FDA Strategy AssessmentA detailed breakdown of FDA's latest RTA updates and how they affect your premarket notification submission strategy and timeline.
Read Article →How the FDA's Quality Management System Regulation (QMSR) aligns with ISO 13485 and what it means for your QMS documentation strategy.
Read Article →A comprehensive guide to drug-device combination product designation, primary mode of action analysis, and intercenter regulatory coordination at FDA.
Read Article →Best practices for pre-IND meeting requests, Phase 1 IND content requirements, and how to avoid the most common FDA deficiencies in first-in-human studies.
Read Article →A practical framework for preparing Clinical Evaluation Reports (CER) that meet EU MDR Article 61 and MEDDEV 2.7/1 Rev 4 requirements for Notified Body review.
Download PDF →Step-by-step guidance for writing a competitive NIH SBIR Phase I application — from specific aims through innovation and approach sections for device-focused grants.
Read Article →Practical tools and checklists used by our consultants — available to you at no cost.
Comprehensive 510(k) submission readiness checklist covering all required sections per FDA guidance and common deficiency areas.
Download →Design History File template package including design plan, inputs/outputs, verification protocols, and design review templates.
Download →Hazard analysis and risk management file template aligned to ISO 14971:2019 for medical device risk management programs.
Download →Whether you're preparing your first FDA submission, recovering from an RTA or 483, remediating a Quality Management System, or navigating a combination product pathway — our team will assess your situation and tell you exactly what's needed to move forward.
A no-obligation 30-minute review of your product, current status, and regulatory pathway — with clear next steps to get FDA-ready faster.
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At the forefront of innovation, our expertise in Combination Products sets us apart. Defined by FDA CFR Part 4, combination products represent a unique intersection of drug, device, and/or biologic elements, each bringing its own set of complexities and regulatory challenges. Navigating this intricate landscape requires a deep understanding of multifaceted regulatory requirements, along with the ability to seamlessly integrate diverse technologies and therapeutic modalities. Our team excels in synthesizing these elements, ensuring that your combination product not only meets rigorous FDA and global standards but also advances the frontier of patient care.
Contact us to discuss how MEDEVICE™ can support your Combination Products needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your combination products needs.
Get Your FDA Strategy AssessmentIn today's world of complex medical device products and ever-changing regulatory requirements, specialized design control resources are invaluable to ensure your medical device is in compliance and designed right the first time. We specialize in design control solutions that satisfy the requirements of ISO 13485 and FDA CFR 21 Part 820.30.
Contact us to discuss how MEDEVICE™ can support your Design Controls needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your design controls needs.
Get Your FDA Strategy AssessmentComplying with ISO 14971 can be challenging. The ISO 14971 Medical Device Risk Management standard requires you to identify all hazards associated with your Medical Device, estimate and evaluate the associated risks, control the risks, and to monitor the effectiveness of all controls. Risk Management spans throughout the product life cycle from the design phase through the commercialization, production and post-production phases. We have expertise in the application of ISO 14971 risk management for medical devices and combination products.
Contact us to discuss how MEDEVICE™ can support your Risk Management needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your risk management needs.
Get Your FDA Strategy AssessmentTechnology is changing every day at an extraordinary rate and having the right design & development resources for your projects has never been more critical. We specialize in translating product concepts into verified and validated designs that meet FDA and international regulatory requirements. Our engineers bring deep expertise across mechanical, electrical, software, and systems disciplines for medical devices and combination products.
Contact us to discuss how MEDEVICE™ can support your Design & Development needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your design & development needs.
Get Your FDA Strategy AssessmentDeveloping Medical Devices and Combination Products is complicated. Integrating technical challenges, with teams, and changing regulation on a tight budget and timeline calls for top notch Project Management. We provide project managers that specialize in using standard project management methodologies to ensure your project remains on schedule and budget. Our project management consultants have deep technical expertise in medical device and pharmaceutical product development along with excellent personal and communication skills.
Contact us to discuss how MEDEVICE™ can support your Project Management needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your project management needs.
Get Your FDA Strategy AssessmentQuality is becoming more and more important in today's medical device and combination products industry. Companies need to make sure they have the right quality resources on board and that quality is fully integrated into their culture. We provide comprehensive quality assurance consulting services ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR requirements.
Contact us to discuss how MEDEVICE™ can support your Quality Assurance needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your quality assurance needs.
Get Your FDA Strategy AssessmentWe specialize in helping companies create regulatory strategies and submissions, with global experience in Medical Devices, Pharmaceutical Products, and Combination Products. Our regulatory affairs consultants guide you through the full regulatory pathway from strategy development through submission and approval, providing expert management of FDA correspondence and pre-submission meetings.
Contact us to discuss how MEDEVICE™ can support your Regulatory Affairs needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your regulatory affairs needs.
Get Your FDA Strategy AssessmentHuman Factors Engineering (HFE) ensures that medical devices and combination products are designed for safe and effective use. We provide expert HFE consulting aligned with FDA's guidance on applying human factors to medical devices and IEC 62366-1:2015. Our team helps you integrate usability engineering throughout the design control process, reducing use-related risk and strengthening your regulatory submissions.
Contact us to discuss how MEDEVICE™ can support your Human Factors needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your human factors needs.
Get Your FDA Strategy AssessmentDHF remediation can have a major impact on your organization. If not completed properly, the significant amount of rework that usually has to occur can have a major financial impact to your bottom line. Make sure you get it completed right the first time by letting us lead the way. We have remediated many product files for combination products and medical devices that have passed FDA and CE related inspections.
Contact us to discuss how MEDEVICE™ can support your DHF Remediation needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your dhf remediation needs.
Get Your FDA Strategy AssessmentIf you are looking for a way to fund your existing small company or startup, NIH SBIR/STTR funding can be a great non-dilutive option for you. MEDEVICE™ has helped clients raise millions of dollars in NIH SBIR/STTR funding. We assist clients in developing high quality NIH SBIR and STTR grant proposals in the medical device, pharmaceutical, and combination products industries. Clients work directly with our Grant Writing Specialists, who provide expertise in obtaining grant funding in the client's technical field. Our services include writing and submitting full proposals as well as critical scientific review and editing to increase the competitiveness of the grant applications.
Contact us to discuss how MEDEVICE™ can support your NIH SBIR/STTR Grant Writing needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your nih sbir/sttr grant writing needs.
Get Your FDA Strategy AssessmentModern statistical techniques are essential throughout the medical device and pharmaceutical product lifecycle. We apply rigorous statistical methodology compliant with FDA 21 CFR §820.250, ICH E9, and relevant ISO standards to support your design verification, clinical studies, process validation, and regulatory submissions. Our biostatisticians bring deep expertise in medical device and pharmaceutical statistics.
Contact us to discuss how MEDEVICE™ can support your Statistical Analysis needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your statistical analysis needs.
Get Your FDA Strategy AssessmentIf you are starting or running a medical device or pharmaceutical startup, our team can help make sure you have the right processes in place to succeed. We have experience starting medical device companies from scratch and taking them to a commercial exit. From branding and niche analysis through regulatory strategy, funding, and commercialization, we provide the full spectrum of startup support to help you build a successful medical device or pharmaceutical company.
Contact us to discuss how MEDEVICE™ can support your Startup Business needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your startup business needs.
Get Your FDA Strategy AssessmentAt the heart of our services lies the Combination Products End to End Integrated Device Solution, an offering tailored for clients navigating the complexities of combination product development. Our role transcends traditional boundaries, positioning us as the Technical Project Manager for the device aspects of your combination product development project. We can serve as your full device organization or piece us in as needed. We seamlessly integrate with your pharmaceutical, biologic, or internal teams to deliver a fully compliant, commercially ready combination product.
Contact us to discuss how MEDEVICE™ can support your Combination Products End to End Integrated Device Solution needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your combination products end to end integrated device solution needs.
Get Your FDA Strategy AssessmentDHF remediation can have a major impact on your organization. Furthermore, if not completed properly the significant amount of rework that usually has to occur can have a major financial impact to your bottom line. Make sure you get it completed right the first time by letting us lead the way. We have remediated many product files for combination products and medical devices that have passed FDA and CE related inspections. Our integrated DHF Remediation program provides a full-scope, project-managed engagement to bring your Design History File into complete compliance.
Contact us to discuss how MEDEVICE™ can support your DHF Remediation needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your dhf remediation needs.
Get Your FDA Strategy AssessmentWe can help you create your Quality System from start to finish or remediate your existing quality system. We have the experience, templates, and systems to make sure your Quality System is ISO 13485 compliant. Our Quality System Implementation program provides a fully managed engagement to design, build, document, and deploy a complete Quality Management System that satisfies FDA 21 CFR Part 820 (QMSR), ISO 13485:2016, and EU MDR requirements.
Contact us to discuss how MEDEVICE™ can support your Quality System Implementation needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your quality system implementation needs.
Get Your FDA Strategy AssessmentWe can manage your product development project from concept to launch or piece us in as needed. If you're starting a new project our talented team of engineers will help you translate your product idea into specific user needs and design input requirements that can be verified and validated in compliance with FDA and international regulatory requirements. Next, we generate concepts and prototypes for user feedback. Once your final concept is chosen we take it through our rigorous design control process — ensuring every step is documented, traceable, and ready for regulatory submission.
Contact us to discuss how MEDEVICE™ can support your End to End Product Development needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your end to end product development needs.
Get Your FDA Strategy AssessmentAre you missing a critical function or discipline within your company? For this situation, we offer our Outsourced Partner Model. We offer this service for all our core consulting areas. This solution works great for our clients who do not want to build out a full function or discipline for a specific need of the company. Under this model, MEDEVICE™ becomes your embedded regulatory affairs, quality, engineering, or clinical team — operating as a seamless extension of your organization on a sustained retainer basis.
Contact us to discuss how MEDEVICE™ can support your Outsourced Partner needs.
Find Your Regulatory Pathway →Get a free FDA Strategy Assessment — we'll map the fastest compliant pathway for your outsourced partner needs.
Get Your FDA Strategy AssessmentRefuse to Accept letters, Additional Information requests, and inspection findings almost always trace back to the same handful of gaps — missing design control deliverables, incomplete risk files, unclear regulatory pathway selection, or a quality system that isn't quite ready for scrutiny.
The FDA Readiness Checklist gives you a structured way to self-assess across the areas FDA reviewers focus on most — so you walk into your submission with confidence, not surprises.
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Skip the self-assessment — talk to a regulatory expert and get a tailored FDA strategy for your product.
Get Your FDA Strategy AssessmentMost 510(k) delays come from avoidable gaps: weak predicate justification, incomplete performance testing, or missing design control documentation. We help you build a submission that's complete the first time.
Explore This Pathway →PMA submissions carry the highest regulatory bar — clinical evidence, manufacturing readiness, and a comprehensive quality system all under scrutiny. We help you build a PMA strategy that anticipates FDA's questions before they're asked.
Explore This Pathway →Combination products sit at the intersection of CDER, CDRH, and CBER requirements. Without the right strategy, companies lose months to jurisdictional confusion, conflicting requirements, and disconnected workstreams. We unify it all under one regulatory strategy.
Explore This Pathway →From pre-IND planning through NDA/BLA submission, every stage carries its own risks — clinical hold triggers, CMC gaps, and Additional Information requests that stall momentum. We help you anticipate FDA's questions and keep your program moving.
Explore This Pathway →Get a free FDA Strategy Assessment and we'll help you determine the right classification and pathway.
Get Your FDA Strategy AssessmentMost 510(k) delays come from avoidable gaps: weak predicate justification, incomplete performance testing, or missing design control documentation. We help you build a submission that's complete the first time.
Your 510(k) was administratively bounced back before substantive review even started.
You're not confident your predicate device and substantial equivalence argument will hold up.
Bench testing, biocompatibility, or sterilization validation gaps are surfacing late in the process.
You haven't completed the usability validation FDA will expect for your device type.
Your Design History File doesn't yet support a clean traceability matrix for the 510(k).
You don't have a realistic, FDA-aligned timeline for clearance — and investors or leadership are asking.
Confirm device classification, identify and justify the right predicate(s), and define your substantial equivalence strategy.
Prepare and facilitate an FDA pre-submission meeting to validate your testing plan and reduce review-cycle risk.
Build or complete your DHF, traceability matrix, and ISO 14971 risk management file.
Coordinate bench, biocompatibility, sterilization, and human factors testing aligned to FDA expectations.
Author a complete, well-organized 510(k) submission designed to pass Refuse to Accept screening.
Manage Additional Information (AI) requests and FDA correspondence through to clearance.
Start with a free FDA Strategy Assessment tailored to your product category — we'll map your fastest compliant pathway.
Get Your FDA Strategy AssessmentPMA submissions carry the highest regulatory bar — clinical evidence, manufacturing readiness, and a comprehensive quality system all under scrutiny. We help you build a PMA strategy that anticipates FDA's questions before they're asked.
You don't have a validated clinical strategy to support safety and effectiveness claims for FDA.
Your facility and quality system may not withstand a Pre-Approval Inspection (PAI).
Your clinical study design or statistical plan hasn't been vetted against FDA expectations.
Your Class III device includes a drug or biologic component requiring combination product strategy.
Your ISO 14971 risk file doesn't yet reflect the rigor a PMA review demands.
Design verification and validation evidence is incomplete or not yet traceable.
Develop a PMA strategy and engage FDA early through pre-submission meetings to align on clinical and non-clinical requirements.
Design IDE-supported clinical investigations with statistically sound endpoints and sample size justification.
Build a comprehensive DHF and ISO 14971 risk management file that supports a Class III safety and effectiveness profile.
Prepare your facility and QMS for FDA Pre-Approval Inspection (PAI).
Author a complete modular or traditional PMA submission with integrated clinical, manufacturing, and non-clinical sections.
Support advisory panel preparation and manage FDA deficiency responses through approval.
Start with a free FDA Strategy Assessment tailored to your product category — we'll map your fastest compliant pathway.
Get Your FDA Strategy AssessmentCombination products sit at the intersection of CDER, CDRH, and CBER requirements. Without the right strategy, companies lose months to jurisdictional confusion, conflicting requirements, and disconnected workstreams. We unify it all under one regulatory strategy.
You're not sure whether CDER, CDRH, or CBER will lead your review — or how to file a Request for Designation (RFD).
Your drug/biologic team and device team are working in silos, creating conflicting documentation.
The device half of your combination product doesn't have a compliant DHF or risk management file.
Usability studies for the combination product (e.g., autoinjector, inhaler, drug-eluting device) are incomplete.
Your quality system doesn't yet bridge pharmaceutical cGMP and device QSR requirements.
Your submission is delayed waiting on intercenter agreement or consultation between FDA centers.
Determine primary mode of action (PMOA), prepare and file a Request for Designation (RFD) if needed, and define the lead-center submission strategy.
Develop coordinated regulatory plans for the device constituent (510(k)/PMA/IDE) and the drug/biologic constituent (IND/NDA/BLA).
Build the device constituent DHF, traceability matrix, and ISO 14971 risk file integrated with the combination product risk profile.
Conduct formative and summative usability studies aligned to FDA combination product human factors guidance.
Author a unified submission package addressing both CDER/CBER and CDRH requirements with cross-referenced documentation.
Manage intercenter consultations and FDA correspondence across all involved centers through approval.
Start with a free FDA Strategy Assessment tailored to your product category — we'll map your fastest compliant pathway.
Get Your FDA Strategy AssessmentFrom pre-IND planning through NDA/BLA submission, every stage carries its own risks — clinical hold triggers, CMC gaps, and Additional Information requests that stall momentum. We help you anticipate FDA's questions and keep your program moving.
You haven't engaged FDA early enough to validate your nonclinical package and clinical trial design.
Chemistry, Manufacturing, and Controls (CMC) documentation has gaps that could trigger a clinical hold or Refuse to File.
Your statistical analysis plan or endpoints haven't been validated against current FDA expectations.
Your drug or biologic is delivered via a device (injector, pump, inhaler) requiring combination product strategy.
You're approaching submission but modules 1-5 aren't yet integrated into a cohesive package.
You've received an FDA Complete Response Letter or Additional Information request and need an expert-led response.
Develop your nonclinical and clinical strategy and request a Pre-IND meeting to align with FDA before you invest further.
Author a complete IND application with a clinical trial design built on statistically sound endpoints and FDA-aligned methodology.
Build out Chemistry, Manufacturing, and Controls documentation to support clinical supply and eventual commercial manufacturing.
If your product includes a device or delivery system, coordinate device constituent regulatory requirements in parallel.
Author a complete, well-integrated NDA or BLA submission across all required modules.
Manage Complete Response Letters, Additional Information requests, and advisory committee preparation through approval.
Start with a free FDA Strategy Assessment tailored to your product category — we'll map your fastest compliant pathway.
Get Your FDA Strategy Assessment