“Content of Human Factors Information in Device Marketing Submissions” and “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers” are now open for comment.
Revised EU GMP Annex 1 requirements must be fulfilled by August 2023. Designed to protect and increase confidence in the sterility of these products, the new specifications are significant and wide-ranging, spanning the Quality system and the manufacturing process itself. Anna Cluet of Rephine discusses the practical specifics of designing and delivering a fit-for-purpose contamination control strategy.
Microbatteries are on the cusp of a new era as solid-state lithium technology arrives to pack more energy into smaller form factors. These batteries will enable the products they power to be offered in smaller sizes and more comfortable shapes, with enormous implications for future medtech product designs and capabilities, from the convergence of hearables and OTC hearing aids to wearable devices that are used for remote health monitoring and fitness tracking.
Veeva Vault CRM for Medtech is a unified customer relationship management (CRM) and content management application built for medtech sales teams, key account managers and medical affairs professionals.
John Taylor has 30 years of software development and senior leadership experience. Prior to joining ETQ in 2018, he was senior vice president with PTC.
The reality of biased data is becoming all too clear, which raises important questions for clinicians as well as device and drug developers. In a world full of biased data what are the most ethical practices to achieve equitable health care?
It is more important than ever for medical manufacturers to prepare for business interruption due to unexpected damage or natural disasters. From building a recovery team to securing proper insurance, there are many steps device manufacturers can take to recover quickly and easily following a disaster.
Peter O’Blenis, CEO of Evidence Partners, discusses the growing role—and challenges –of literature reviews in the medtech market.
Medtech and Biotech companies that prioritize professional development and career growth can reduce turnover and attract new talent. Here is how one company is standing out in a highly competitive employment market.
“We are excited that organizations like Innovaccer are working to improve trust in clinical data and help ensure the data’s accuracy and broader usability.”
