Resources & Insights
Practical guidance on FDA submissions, the QMSR transition, audits, and quality systems — from a team that lives the requirements.
Insights
May 2026
The FDA QMSR Transition: A Practical Checklist Before February 2026
FDA’s Quality Management System Regulation harmonizes 21 CFR 820 with ISO 13485 on February 2, 2026. Here is what to actually do, whether you are ISO 13485-certified or on a legacy QSR system.
Read more →May 2026
What Hosting Client Audits Every Month Taught Us About Passing FDA Inspections
Most device companies sit for one external audit a year. As an FDA-registered facility, we get audited by our customers several times a month. Here is what that frequency teaches you.
Read more →May 2026
Why a Pre-Submission Is the Cheapest Insurance in Your 510(k)
The most common cause of 510(k) delay is testing that has to be repeated. A Pre-Submission is how you avoid it — and why it almost always pays for itself.
Read more →Published Articles
Selected articles by our team published in the medical device trade press.
- Your 510(k) Hasn’t Sailed Through. Now What? ↗MedDevice Online
- Biocompatibility Testing Tips To Speed Your Medical Device To Market ↗MedDevice Online
- The Road To ISO 13485 Certification: Tips For Effective Audits ↗MedDevice Online
- How To Untangle Your Medtech Regulatory, Engineering, and Business Decisions ↗MedDevice Online
- 5 Key Steps For FDA Q-Submissions ↗MedDevice Online
Have a question we should write about?
Or a real one about your own program? We answer both.
Request a Consult