What’s new on the blog.
How to Structure a New Medical Device Business
There’s More to Being a Medical Device Business than IP and R&D An emerging medical device business tends to focus their energy on product development and…
Meet FDA Requirements for Medical Device Company Compliance
Most medical device executives know they need FDA clearance to legally market and promote their product in the U.S. Beyond FDA approval, understanding how to effectively…
21 CFR Part 820 Ensures Your Device is Safe and Effective
An Early Practical Handle on 21 CFR Part 820 Improves Your Medical Device Business Operations The purpose of regulatory affairs is to ensure that your company…
What Happens When the FDA Says, “I Don’t Know”
The FDA tries to track what are called “emerging safety signals.” In 2016, a study found a possible link between reduced leaflet mobility in TAVRs and…
Advocate vs. Adversary: Why Your Perception of the FDA Can Affect Your Submission
Ensuring an FDA 510(k) submission is done properly is critical to getting your medical device into the market and monetizing your development. And the speed with…
Regulating Medical Devices Shapes Industry for the Better
This article originally appeared in Business Worldwide magazine. It’s fashionable to be anti-regulation in business today. But sometimes regulation is central to how a sector operates.…
Take the Document Control System Quiz (SPOILER: it’s pass/fail there’s no partial credit)
How do you know your Document Control System is working properly within your medical device company? Take this quick Document Control Health Check-Up Questionnaire: If you…
5 Questions to Evaluate your Records v. Documents Management Practices
Documents, documents everywhere. But which are the records, which are documents, what is the difference and why does it matter? Even start-up medical device companies are…
eSTAR Submissions, a New Method for US FDA Medical Device Submissions
Identifying and Overcoming eSTAR Challenges for a Successful Submission As of October 1, 2023, all 510(k) submissions must be submitted as electronic submissions using eSTAR through…