Manufacturers of medical devices are required to comply with QMS ISO 13485, MDSAP and the applicable regulatory requirements.
With over three decades of experience in the medical device sector, we possess a wealth of expertise having worked as both a medical device manufacturer and regulatory consultant.
KD&A supports companies to meet QMS ISO 13485, MDSAP and other applicable requirements through providing QMS creation, implementation, audit and maintenance services.
Other relevant services:
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