The PCR and real-time PCR molecular diagnostics was valued at $4 billion in 2019.
Medical device security needs to address the cyber-physical threats, not just patient health information risk.
Under the new regulation, medtech manufacturers can no longer defend their claims with limited clinical data; the depth, breadth and scrutiny on clinical data is much more rigorous.
To achieve success in this market, device manufacturers should consider working with providers to help contain costs and enhance outcomes.
No longer just “the big company advantage,” Arlen Ward discusses how CM&S is an accepted and viable device industry path to market for large and small medical device makers alike.
The agency stated that Battelle Memorial Institute is not in compliance with reporting requirements related to its CCDS.
With digitalization impacting all areas of manufacturing operations, it should come as no surprise that medical device producers must adapt or risk missing the next wave of performance and product improvements.
The collective variables within the healthcare system make it difficult to guarantee device security all the time.
The center intends to facilitate partnerships, exchange knowledge and promote innovative regulatory approaches.
The non-profit organization states that 60–70% of KN95 masks tested do not filter 95% of aerosol particulates.