The sudden closure of a medical device sterilization plant in February and a second plant closure planned for later this year have raised questions about the effects on medtech manufacturers.
Medical Device
What you Need to Know About Reusable Devices and Europe’s MDR
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)
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.
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.
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...
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,...
A Manufacturer’s Guide for EU MDR
From 26th May 2020 MDR will come in to effect in EU Member States. This regulation will apply to all manufacturers who are selling medical devices within Europe. How EU MDR affects medical device manufacturers With recent updates to ISO 10993-1 and the MDR on track to...
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 May 26, 2020, according to a new survey from the Regulatory Affairs Professionals Society (RAPS) and KPMG....
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
