Blog
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...
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...
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...
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,...
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...
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...
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...