Advice on how medtech companies should approach their plan for regulatory testing.
Technical Expertise
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.
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.
Radiation Sterilization: Verifying Dose Survivors
A wealth of knowledge was gained from a historic data review of radiation dose verification failures. Our experts highlight the importance and application of this data set as well as its benefit to device manufacturers. In last week’s blog post, we highlighted the...
Our All-Inclusive Approach to Microbial Identification
WuXi AppTec’s robust approach to microbial identification (ID) testing surpasses the industry standard offered by other laboratories. Our clients come to us when a microbial excursion has occurred. Understanding what the microbial contaminants are, and where they have...
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 Regulation (MDR) will require submissions to be approved by May 26, 2020 to maintain a presence in the EU medical...
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...
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 work to do. With the E.U.’s Medical Device Regulation (MDR) coming into effect in less than a year, medical...
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, European medical device requirements present greater regulatory hurdles. The impending updates aim to minimize...
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...
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
