There have been 29 complaints, including 19 serious injuries and two deaths, related to the device issue.
All commercial, clinical, R&D and manufacturing activities surrounding the product will end.
Physicians need technology that helps them track disease progression and response to therapy.
The non-profit organization states that 60–70% of KN95 masks tested do not filter 95% of aerosol particulates.
Across Asia, government health and safety authorities have tightened regulations on medical devices this year, as markets continue to experience rapid change, and as the devices themselves gain sophistication and complexity at a blistering pace.
Part one of this series looks at the claims brought against manufacturers of diagnostic test kits.
The medical device industry is pressured to aid those stricken by the pandemic, while at the same time working to mitigate increased risks usually associated with hurried manufacturing and quality control procedures.
User needs and expectations continue to advance. Medical device technology needs to keep pace. For a successful design, take the following requirements into consideration.
Investments in new processes and systems must satisfy the needs of the authorities and ensure patient safety and public confidence. Getting it right is likely to be expensive. but regulatory compliance shouldn’t be viewed purely as a cost center.
As the proliferation of connected and complex medical devices grows, healthcare providers are more susceptible to cyberattacks.