ISO 11607 and MDR—package testing and validation impacts Medical device manufacturers around the world are working to ensure their package designs are in line with the recent updates to ISO 11607, Part 1 and Part 2, and the Medical Device Regulation (MDR). Britt...
Medical device manufacturers have a lot to keep track of these days. Between ongoing device development and preparing for the European Union’s impending Medical Device Regulation (MDR), it’s more important than ever to maximize every partnership. Outsourcing device...
With the MDR journey well underway, device manufacturers should have their gap analyses complete and road maps to the finish line thoroughly planned out. However, the industry is behind. Where OEMs Are Now vs. Where They Should Be Many manufacturers are running behind...
Anyone involved in medical device development and manufacturing has undoubtedly heard of the regulatory changes happening in the EU beginning May 2020, lest they have been living under the proverbial rock. So much has been written and discussed, in fact, that it can...
Medical device manufacturers are under serious pressure to get in gear and conduct their pre-clinical device testing—and fast. Europe’s Medical Device Regulation (MDR) will require submissions to be approved by May 26, 2020 to maintain a presence in the EU medical...
Updates to ISO 11607, Parts 1 and 2, have left many medical device manufacturers wondering about the future of their packaging designs. These changes come at a stressful time for OEMs, as Europe is also in the process of replacing the current Medical Device Directive...
The E.U.’s new medtech regulations are scheduled to go into effect in 2020, giving manufacturers who want to continue selling their devices in Europe lots of work to do. With the E.U.’s Medical Device Regulation (MDR) coming into effect in less than a year, medical...
With recent updates to ISO 10993-1 and the Medical Device Regulation (MDR) on track to replace Europe’s current Medical Device Directive (MDD) next year, European medical device requirements present greater regulatory hurdles. The impending updates aim to minimize...
With recent updates to ISO 11607, Part 1 and Part 2, and the Medical Device Regulation (MDR) on track to replace Europe’s current Medical Device Directive (MDD) in 2020, medical device manufacturers are working hard to ensure their package designs are in line with...
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
