Blog
Getting the Most out of Your Lab Partnership Ahead of the EU’s MDR
Medical device manufacturers have a lot to keep track of these days. Between ongoing device development and preparing for the European Union’s impending...
Preparing for MDR: Test In-House or Outsource?
With the MDR journey well underway, device manufacturers should have their gap analyses complete and road maps to the finish line thoroughly planned out....
Report: Most Medical Device Makers Not Ready to Meet E.U. MDR Deadline
Only about a fourth of medical device companies plan to be fully compliant with the European Union’s new Medical Device Regulation when it goes into effect on...
An MDR Roundup
Anyone involved in medical device development and manufacturing has undoubtedly heard of the regulatory changes happening in the EU beginning May 2020, lest...
Preparing for MDR: Partner Up
Medical device manufacturers are under serious pressure to get in gear and conduct their pre-clinical device testing—and fast. Europe’s Medical Device...
Guide to Package Integrity & Validation Testing Under ISO 11607 and MDR
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...
Countdown to MDR: Do you know your options?
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...
The OEM’s Roadmap to Navigating MDR
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,...
Package Testing and Validation: Interplay Between ISO 11607 Updates and MDR
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...
Regulations: Preparing for the EU’s MDR
Anticipation is growing for 2020, with the world’s top athletes preparing to compete in the summer Olympics and medical device professionals feverishly...