Regulatory & Quality Strategy for Medical Devices
Regulatory strategy built to survive an audit.
Vellum Strategy Group provides senior regulatory and quality advisory for medical device manufacturers, drawing on more than 15 years of cross-functional expertise. Hands-on counsel for the submissions, audits, and remediation work that carry the highest stakes.
What We Handle
Five practice areas, senior-level accountability.
Senior regulatory expertise leads the work: the same caliber carried out inside three of the industry’s largest regulated manufacturers, applied to your program.
Regulatory Strategy & Global Submissions
End-to-end pre- and post-market strategy: FDA 510(k), PMA, De Novo, Pre-Submissions (Q-Subs), and EU MDR technical documentation alignment.
Crisis Management & Remediation
Executive leadership on FDA Form 483 responses, Warning Letter remediation, CAPA overhauls, and systemic compliance recovery.
QMS Design & Auditing
Comprehensive quality management system design, overhaul, and auditing under 21 CFR 820 (QMSR), ISO 13485, and MDSAP.
Design Controls & V&V
Technical writing and engineering governance for design history files (DHF), risk management files (ISO 14971), and verification/validation protocol authoring and execution oversight.
Change Control & Lifecycle Governance
Strategic impact assessments, design change evaluations, and regulatory gap analyses across complex hardware, software, and material changes.
See the full scope
Detailed capabilities across every practice area, with the frameworks each one runs on.
Diagnostic Tools
Know your exposure before an auditor finds it.
Five short, interactive assessments built from the same frameworks used in FDA and Notified Body reviews. Take one now and leave with a risk-severity assessment of your program, not just a lead form.
Sample Output
Risk Severity Matrix
CAPA backlog, change control gaps, and complaint-handling flow scored against 21 CFR 820 / QSMR core vulnerability areas.
Engagement Model
Built for direct, milestone-based engagements, currently open on a W-2 or contract basis.
Vellum Strategy Group is structured to operate as a Corp-to-Corp partner within CRO and prime vendor networks, alongside W-2 and contract engagements. New engagements are currently open on a W-2 or contract basis; Corp-to-Corp partnerships are not being accepted at this time.
Industry Trends
FDA enforcement is climbing, and it's concentrated in three places.
FDA issued 59 medical device warning letters in 2025, up from 45 in 2024. Quality system violations drove the majority of them, and the same three findings have led the list for two years running.
59 vs. 45
Medical device warning letters issued in 2025, up from 2024. Quality system regulation violations were the most common allegation, cited in 38 of the 59 letters.
Same three findings, two years running
Design Controls (26 letters), CAPA (26 letters), and Complaint Files (25 letters) have been the top three QSR citations for two consecutive years.
QMSR's first test
The Quality Management System Regulation took effect February 2, 2026, replacing 21 CFR 820. How FDA cites under the new framework is still an open question.
Source: Covington & Burling LLP, Quarterly Medical Device Warning Letters Update: October – December 2025 and 2025 Annual Summary (Feb. 2026).
Read the Full BreakdownReady When You Are
Engage before the deadline becomes the crisis.
A confidential introductory call takes thirty minutes and gives you a clear assessment of where your program stands.
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