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:
Despite the Class Ir MDR deadline extension, manufacturers must keep pace with compliance efforts to prepare for more potential, unpredictable turns.
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...
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.
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.
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)
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.
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.
With the MDR journey well underway, device manufacturers should have their gap analyses complete and road maps to the finish line thoroughly planned out. However, the industry is behind. Where OEMs Are Now vs. Where They Should Be Many manufacturers are running behind...
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...
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
