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Month: November 2022

Auditing a QMS According to ISO 13485

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Medical device manufacturers must first ensure that their QMS conforms to the specified requirements and is effectively implemented and maintained. On the path towards ISO 13485 certification, manufacturers should undergo an internal audit and then an external certification audit. This article supports manufacturers in understanding the auditing process toward ISO 13485 certification.

NAMSA Transforms Integrated MedTech Commercialization Solution: The NAMSA APEX Program

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NAMSA announced today the transformation of its integrated MedTech commercialization solution: the NAMSA APEX Program. NAMSA’s strategic outsourcing solution is introduced at a time when the MedTech industry is experiencing changing regulatory requirements and expanding clinical evidence demands