M & A: Forensic Regulatory Assessment is Essential
Without It- You Pay for Your Acquisition Over and Over Again Mergers and Acquisitions within the medical device community contribute to the vitality of the industry, but far too many companies only think about forensic accounting as a necessity. All too often the merged company will experience remorse because the due diligence failed to account for systemic regulatory negligence. M & A’s would never occur without forensic financial review. Yet […]Read More
21 CFR 820 for QSR is a US regulation- not an option
These days we read a lot about the US FDA “incorporating” ISO 13485. The US Food and Drug Administration proposed a rule in early 2022 to harmonize its medical device quality management system (QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard. It has not happened yet! Too many folks are over interpreting the FDA intentions; assuming that if their company complies with ISO 13485:2016 they are […]Read More
PRE-SUB 510(K)*– Yes or No?
Don’t file a Pre-Sub for a 510(k) when you don’t need one. A Pre-Sub for a 510(k) should not be seen as a way to avoid doing your own homework. A Pre-Sub is not without risk and can be time consuming. The potential benefits of receiving feedback to your plans should clearly offset the risk of getting answers you don’t want. There are easier ways to confirm you are on […]Read More
Additive 3D Printing: We wrote the book
Paladin Medical® wrote the book on 3D printed medical devices. Well, not the book exactly, but the first 510(k) for a 3D-printed medical device. Paladin Medical® secured the Stratasys FDM MedModeler 510(k) #971290 as a radiological accessory. Medical devices produced by 3D (additive) Manufacturing are the next big thing. But the US FDA issued a guidance on December 5, 2017: Technical Considerations for Additive Manufactured Medical Devices; and they have […]Read More
3D Printed Products: What FDA expects you to know
The regulatory classification of your device will most likely be the same regardless of the manufacturing methods, but for 3D printed products (additive manufacturing) FDA stresses the importance of Design Control and therefore, design validation. Some companies who have a Class I device may consider that the quality system regs (21 CFR 820) don’t apply to them, but many Class I devices are not “GMP-exempt”. And although Design Controls do […]Read More
3D Printing: Not quite a Star Trek replicator!
When Covid-19 arrived on the scene, many owners of 3D printers came to the rescue. Making a medical device with a 3D printer was clearly child’s play. Headlines were filled with stories of students making face shields and respirator masks in their bedrooms and sending them off to the needy healthcare professionals. There were few if any headlines concerning harms from such homemade medical devices so presumably they worked adequately, […]Read More