Regulatory & Quality Strategy for Medical Devices
Regulatory Strategy for Audit Readiness
Vellum Strategy Group provides senior regulatory and quality advisory for medical device manufacturers. Hands-on counsel for submissions, audits, and remediation.
Practice Areas
Our Practice Areas
Regulatory and quality strategy across the product lifecycle, grounded in hands-on work with medical device manufacturers.
Regulatory Strategy & Global Submissions
The fastest defensible path to clearance or approval: 510(k), PMA, De Novo, Pre-Submissions, and EU MDR technical documentation.
Crisis Management & Remediation
Leadership after the FDA or a Notified Body finds a problem: Form 483 responses, Warning Letter remediation, and CAPA overhauls.
QMS Design & Auditing
Designing and auditing quality management systems under 21 CFR 820 (QMSR), ISO 13485, and the Medical Device Single Audit Program.
Design Controls & V&V
Proving a device design meets user needs before it ships: design history files, ISO 14971 risk management files, and verification and validation protocols.
Change Control & Lifecycle Governance
Deciding whether a design or manufacturing change needs a new submission or can proceed as a documented update, supported by impact assessments and gap analyses.
Full Scope of Services
Detailed capabilities and the frameworks behind each practice area.
Diagnostic Tools
FDA and EU MDR Risk Diagnostics
Five interactive assessments built around the records the FDA and Notified Bodies review. 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 / QMSR core vulnerability areas.
Industry Trends
FDA Warning Letter Trends for Medical Devices
Medical device warning letters numbered 39 in FY2024, 54 in FY2025, and 56 in FY2026, counted from the FDA’s own public postings.
Quality System Violations Behind the Increase
Quality system regulation violations were the most common allegation category by far, cited in 45 of FY2025’s 54 letters.
Most-Cited Quality System Categories
Design controls led FY2024. CAPA led FY2025 and FY2026 by one letter each, among letters that allege a quality-system violation.
ISO 13485 Clauses Cited After the QMSR
Of the letters issued since the QMSR took effect on February 2, 2026, 7 cite ISO 13485 clauses by number, through letters posted October 27, 2026. Two of the 7 cite no section of the CFR at all.
Insights and Resources
Analysis and Reference
Failure to Follow Written Procedures in a 2026 Warning Letter
A May 2026 warning letter cites five ISO 13485 clauses and no section of the CFR. Three of the findings say the firm did not follow its own written procedures.
All 5 ArticlesMedical Device Glossary
Quality and regulatory terms tied to their governing rule or standard, marked by region.
Open the GlossaryResource Library
Companion sheets, guides, and enforcement data.
Browse the LibraryRecent LinkedIn Posts
Follow VSG on LinkedIn
On September 18, 2026, the FDA issued draft guidance that would require the eSTAR for original PMAs and four kinds of PMA supplement, including 30-day notices.View on LinkedIn ↗
Complaint files used to be 21 CFR 820.198. That section was removed from Part 820 on February 2, 2026.View on LinkedIn ↗
Feedback on the FDA's generative AI discussion paper closes on Monday October 19, 2026.View on LinkedIn ↗
The FDA has issued draft guidance on what a company submits to market a surgical robot.View on LinkedIn ↗
Availability
Not Currently Accepting New Engagements
Vellum Strategy Group is not currently accepting new client engagements. The site remains open for general inquiries, and we follow up as availability opens.
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