Mitigating risk of failure is one of the most important disciplines to perform for medical device manufacturers, and for the last couple of years, it has become an increasingly difficult discipline to master.
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.
Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and clinical data may allow a clearer understanding of regulatory expectations to emerge.
EU regulations require manufacturers of medical devices and systems prove the single-fault safety of their products. However, it is not clearly defined in detail how to comply with these requirements. This article explains which technical and legal requirements apply and which aspects should be considered during development.
Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.
While connected capabilities and wireless technology certainly lead to greater patient care, they also expose devices to greater cybersecurity risks.
This year’s virtual event features experts from medical device companies, hospitals and government organizations.
This online series of workshops will arm you with the information you need to overcome challenges and achieve compliance with EU MDR.
The hot issues are related to compliance, EU MDR and recalls.
This series makes the argument for probability assessments in HFE/UE for medical devices and how to incorporate it into the paradigm.