Policies & Regulations
Secure by Design: Developing Cybersecure Medical Devices
As software-based medical devices become increasingly connected, cybersecurity must be considered right from the first design stages in order to protect patients’ health and personal data. However, in many instances there are no standards or clear guidelines for the medical sector……
2021年7月27日
One Year After EU MDR Delay, Plenty of Barriers to Compliance Remain
Manufacturers continue to face a lack of clarity, high costs, and manual processes in order to comply with the new medical device regulation (EU MDR), according to a recent survey. These results come one year after the regulation’s postponement and a few weeks before the new validity date……
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2021年5月19日
Chemical Compliance Requirements for EU MDR and IVDR
Is your medical device or diagnostic in compliance with this small, but essential, sub-section?……
2021年4月28日
