If your organization is planning for a submission under the Medical Device Regulation (MDR), it’s important to consider outsourcing your testing needs to a testing lab. Working with an experienced partner that is well-versed in the latest standards can save you time,...
Every great chef has a secret “something” to their name – a recipe, a technique, an ingredient. It stands to reason that a lab largely concerned with chemistry would also have its own special something. After all, cooking is a form of chemistry, isn’t it? While some...
New identification standards are putting pressure on manufacturers' submissions. Make sure your sensitivity is up to regulations. Medical Device Regulation (MDR) and recent International Organization for Standardization (ISO) revisions emphasize the importance...
A risk-based approach that tailors test requirements to the specific risks of each device.
Product adoption for radiation sterilization can cut costs and save time today and in the future.
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:
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.
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.
