Regulatory/Legal
Nov 17, 2016
Here are ten strategies that medical device makers of all sizes can use to build a solid patent portfolio. Hyeongsu Rick Park and Ron Schoenbaum Medical...
Nov 16, 2016
FDA launched two major initiatives in 2016—cybersecurity requirements and a national system for real-world device monitoring. Jim Dickinson The last year of...
Nov 15, 2016
Medical device makers should be aware of how FDA decides to regulate wound dressings containing drugs, since that regulation is likely to be broadly applied to...
Nov 07, 2016
Who is repairing your medical devices? FDA should extend its regulatory oversight to the entities that service medical devices. Patrick Hope Who fixes your...
Oct 31, 2016
During a State of the Union lecture, CDRH director Jeffrey Shuren highlighted early wins of FDA's shift toward postmarket surveillance, novel approaches to...
Oct 24, 2016
Here's what the proposed Medical Device User Fee Amendments IV, slated to take effect in October 2017, mean for the device industry. Heather Rosecrans, FRAPS...
Oct 17, 2016
A recent report from the Medical Device Innovation Consortium (MDIC) takes a small step toward a system that would ease FDA's burden by encouraging aggressive...
Oct 17, 2016
Learn what it takes to obtain the ISO 17025 laboratory accreditation from professionals who recently completed the process. Gaetano (Tom) Rizzo, Donna Ventura...
Oct 06, 2016
Digital medicine is expected to play a major role in the future of healthcare, but stakeholders still need to iron out the wrinkles. This is the state of...
Sep 28, 2016
Seven major private payers and health technology assessment groups have raised their hand to give interested medical device companies early feedback on...