IEC 62304 Medical Device Challenges | Compliance Group Inc


Compliance with the International Electrotechnical Commission (IEC) 62304 standard is vital for ensuring the safety and effectiveness of medical device software throughout its life cycle. However, medical device manufacturers face numerous challenges in meeting these requirements. This standard examines critical challenges related to software development, verification, and validation, as well as risk management and documentation under IEC 62304. Furthermore, the abstract discusses practical strategies to navigate these hurdles successfully, enabling manufacturers to produce safe and reliable medical devices while meeting regulatory obligations efficiently.

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IEC 62304 | How to Overcome the Challenges in Medical Device Manufacturing? - (complianceg.com)


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