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.

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.