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
Choosing and executing the fastest defensible path to clearance or approval: FDA 510(k), PMA, De Novo, Pre-Submissions (Q-Subs), and EU MDR technical documentation alignment.
Crisis Management & Remediation
Executive leadership once FDA or a Notified Body has already found a problem: Form 483 responses, Warning Letter remediation, corrective and preventive action (CAPA) overhauls, and systemic compliance recovery.
QMS Design & Auditing
Building and auditing the quality management system a device business runs on, under 21 CFR 820 (QMSR), ISO 13485, and the Medical Device Single Audit Program (MDSAP).
Design Controls & V&V
Verifying a device design meets user needs before it ships, documented in design history files (DHF), ISO 14971 risk management files, and verification/validation protocols.
Change Control & Lifecycle Governance
Determining whether a design or manufacturing change needs a new regulatory submission or can proceed as a documented update, backed by the impact assessments and gap analyses that decision requires, across 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 interactive assessments built from the same frameworks used in FDA and Notified Body reviews. Each one produces a risk-severity assessment of your program.
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
Open on W-2 and contract terms
Vellum Strategy Group takes on milestone-based projects and ongoing fractional or retainer support, including work placed through CRO partnerships and prime vendor networks. New engagements are open on a W-2 or contract basis; Corp-to-Corp partnerships are not being accepted at this time.
Industry Trends
CAPA is now the top-cited category
54 medical device warning letters in FY2025, up from 39 in FY2024, tracked directly from the FDA's own public postings.
QSR violations drive the FY2025 warning-letter increase
Quality system regulation violations were the most common allegation category by far, cited in 44 of FY2025’s 54 letters.
CAPA’s lead has held for two years running
Design Controls led FY2024 by a wide margin. CAPA pulled ahead in FY2025 (31 letters to 29) and has held the lead into FY2026.
3 of 20 post-QMSR letters omit 21 CFR 820 entirely
Of the letters issued since QMSR took effect February 2, 2026, the FDA has begun pleading violations directly against ISO 13485 clauses in 3 of them, no CFR section at all.
Ready 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.
Get in Touch