Articles
QSR to QMSR: FDA Gives Medical Device Makers Two Years to Comply with New Quality Regulations
QSR will be retired in favor of QSMR In February 2024, the FDA issued final guidance for…
Go-to-Market Medtech Expert Q&A: Haley Schwartz
Today, we interview Haley Schwartz, one of our experts and most respected voices, to…
Weak Cybersecurity Can Now Get Your Medical Device Rejected
As of Oct 1, lax cybersecurity is grounds for FDA rejection and potential criminal…
Safer Technologies Program STeP for Medical Devices
Is STeP right for your medical device? In 2021, due to the success of the Breakthrough…
TAP to Win with the FDA
How to leverage the FDA’s newest pilot program for speed to market and post-approval…
New FDA Breakthrough Guidance: Does Your Device Qualify?
But fast-track designation still may not be the best path to market. On September 14,…
Properly timing compliance with QMS Document and Version Controls
In our first article discussing timing in the context of designing a new medical device,…
Properly timing compliance with QMS Purchasing Controls and Acceptance Activities
In our first article discussing “timing” in the context of designing a new medical…
Pre-Design Control Documentation Strategies
The technical feasibility process (TFP), or the stage in which medical device conceptual…
Analysis of FDA Warning Letter CMS 617539
Warning letters issued by FDA to medical device manufacturers are a significant concern…