Some of the popular Quality management system standards for medical devices industry are listed as under:

ISO 14971:2007 titled as "Medical devices -- Application of risk management to medical devices".
EN 46001:1997 titled as "Specification for application of EN ISO 9001 to the manufacture of medical devices" (Status - Withdrawn).
FDA 21 CFR Part 820 titled "Quality System Regulation".
ISO 13485:2016 titled as "Medical devices -- Quality management systems -- Requirements for regulatory purposes".

ISO 14971:2007 provides a framework for a supplier or medical device producer to recognize the hazards and assess its risk related with use of medical devices, together with those of in vitro diagnostic (IVD) medical devices. ISO 14971 guides companies to assess and determine related risks, to minimize risks, and to keep an eye over the effectiveness of the controls established to mitigate risks.
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