MEDIcept Insights
Health Hazard Analysis Tips
Health hazard analyses (HHAs) are a necessary part of the medical device manufacturing process since the FDA revised Medical Device Good Manufacturing Practices Regulation, 21 CFR Section 820 in 1996. They were replaced with the Quality System regulations and included...
M&A regulatory due diligence
Proper due diligence is important in any corporate merger and acquisition because investing in or acquiring another company is always risky business, but for medical device companies subject to FDA scrutiny, due diligence is absolutely critical. Too many acquiring...
Reducing risk with supplier audits
"Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements." Part 820, Subpart E Section 820.50 Code of Federal Regulations This one, short sentence in the...
HIPAA, Cybersecurity, and Medical Device Manufacturers
Wait a minute, HIPAA regulations have to do with protecting private health information - that's something that hospitals, physicians' practices, and other health organizations have to be concerned about, not medical device manufacturers, right? Wrong. As more and more...
Reducing risk with supplier audits
Are you sure your suppliers meet FDA requirements? “Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.” Part 820, Subpart E Section 820.50 Code of Federal...
Effective FDA Inspection Back Room Management – Tips for start-ups on weathering an FDA inspection
The words “FDA inspection” can strike fear into the hearts of even the most stalwart medical device manufacturers, but with proper preparation and training, you won’t have to sweat the details when the FDA inspectors show up at your facility. Instead, you’ll be...