by Michele Taylor | Apr 28, 2016
September 24, 2016, a date fast approaching, is the deadline for Class II medical devices to be compliant with unique device identifier (UDI) regulations. For compliance, device manufacturers have to submit device identifiers (DI) to FDA for inclusion in the GUDID...
by Michele Taylor | Apr 20, 2016
Earlier this year, FDA released recommendations for medical device manufacturers in managing cybersecurity risks related to safety, efficacy, and integrity of medical devices and patient health. If you haven’t already, take a look at this timely draft guidance from...
by Michele Taylor | Apr 14, 2016
Brandwood Biomedical is hosting a webinar, Post Market Compliance – keeping those hard won registrations. For the latest news on staying on top of your post market obligations including customer feedback, post market reporting, advertising & labeling compliance...
by Michele Taylor | Apr 13, 2016
The Indiana Medical Device Manufacturers Council (IMDMC) is hosting a workshop on April 21st for those new to the medical device industry or for those looking for a regulatory refresher. Pearl Pathways’ own, Gretchen Bowker COO & RAC, FRAPS, will be presenting on,...
by Michele Taylor | Apr 6, 2016
Gretchen Bowker, Pearl Pathways COO and Co-Founder, is teaching a class to Purdue students on the campus of Roche Diagnostics in Indianapolis on “Ethics, Quality and Human Safety in Clinical Trials: The Role of the IRB in Medical Device Studies”. The lecture will be...