To accommodate the high demand and help manufacturers meet the May 26, 2021 deadline, WuXi Medical Device Testing recently expanded its chemistry lab in Minnesota.
Medical Device
Stop Letting GLP Stunt Your Chemistry Studies
The FDA’s Good Laboratory Practice (GLP) regulations have led to some misconceptions for medical device manufacturers (MDMs). To better understand the misconceptions about when to apply GLP testing, I think it’s important to first look at what the FDA GLPs actually say:
Class Ir Extension Granted, but Don’t Slow Down
Despite the Class Ir MDR deadline extension, manufacturers must keep pace with compliance efforts to prepare for more potential, unpredictable turns.
Response to COVID-19: We’re Here For You
As the world faces challenging times, we remain true to our promise to serve and support our customers. We are here to help. Getting lifesaving devices to market has never been so critical, and we’ve taken measures globally to stay resilient and prepared to carry even...
Is Your Testing Program Ready for the EU MDRs?
The European Union’s new Medical Device Regulations (EU MDR) will require that all medical devices – even legacy products – have updated clinical data and technical documentation to support device safety and conformity with the new regulatory standards.
How Should Medtech Manufacturers Cope With Sterilization Plant Closures?
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.
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...
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.