Manufacturers of Class I reusable (Class Ir) medical devices need to identify data gaps and select the appropriate validation study to ensure their devices’ compliance with the European Commission’s Medical Device Regulation (MDR)
MDR
Preparing for MDR: Don’t Forget About Class I Reusable Devices
Class III medical devices are getting a lot of airtime in the discussion about the EU Medical Device Regulation (MDR) preparation, but we can’t forget about reusable devices.
Got Your Game Plan? The OEM Playbook to Navigating Preclinical Device Testing Under MDR and ISO 10993-1
When the Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) in 2020, requirements for medical devices in Europe will present greater regulatory hurdles.
Q&A: MedTech Industry Still Scrambling as MDR Deadline Nears
Advice on how medtech companies should approach their plan for regulatory testing.
MDR Countdown: Know Your Options
Preparing for MDR is a daunting process, but there are steps you can take today to make sure you’re ready. Start by rationalizing your product portfolio.
Preparing for MDR: How to Conduct a Gap Analysis
With the EU Medical Device Regulation (MDR) drawing near, device manufacturers are under intense pressure to get in gear and evaluate their existing pre-clinical data for compliance. After May 26, 2020, all new medical device submissions will be required to meet the...
5 Questions you Need to Ask your MDR Testing Partner
Working with an experienced lab testing partner that is well-versed in the latest standards can save you time, money and manpower – here’s how to vet them.
Why Labs Ask for so Much Info
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 Jones, WuXi AppTec’s manager of package testing services,...
Packaging Q and A
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...
Package Testing and Validation Under ISO 11607 and MDR: What You Need to Know
Changes to ISO 11607 parts one and two have left Medical Device Manufacturers (MDMs) wondering how new requirements will impact their business and efforts to prepare for the EU MDR. These regulatory changes add new requirements for package usability and sterile...
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
