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=== ISO === While not strictly a regulatory body, ISO provides standards documents that are often used as part of the regulation itself, either implicitly or explicitly. A few relevant standards include: * [https://www.iso.org/standard/59752.html ISO 13485 (Medical devices β Quality management systems β Requirements for regulatory purposes)] * [https://www.iso.org/standard/65529.html ISO 60601 (Medical electrical equipment)] Specific auditors, notified bodies, and other organizations will be certified to assess your compliance to the relevant standards.
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