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
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...
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 a stressful time for OEMs, as Europe is also in the process of replacing the current Medical Device Directive...
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 (MDD) in 2020, medical device manufacturers are working hard to ensure their package designs are in line with...
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Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.