There are several critical questions that your internal team should be ready to address when preparing product portfolios and seeking out a CRO.
This new pathway is a considerable change for the medical device industry.
Learn about the new subclass for Class I reusable devices under MDR and the necessary steps to ensure compliance.
Know how IQ, OQ and PQ—the three essential elements of a Quality Assurance System—govern the medtech sector.
The 1000-dollar genome presents a big opportunity in medicine.
The assay provides results in less than 3 hours.
The deal creates the largest global sterilization and lab services operation.
Following a safety alert, the agency issued an update about possible counterfeit raw materials in urogynecologic mesh implants.
Part three of the design verification series discusses in detail the steps that should be taken during testing.
Prior to design verification of packaged products, consider the following process-related elements.