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ISO 13485:2016 Medical Devices - Quality Management System Requirements for regulatory purposes is a document that supersedes ISO 9001, EN 46001, EN 46002, and ISO 13488. It emphasizes meeting regulatory and customer requirements, risk management, and maintaining effective processes. Although not fulfilling the FDA or other foreign regulators' requirements, ISO 13485 certification aligns an organization's management system to the FDA's Quality System Regulation (QSR) requirements and other global regulatory requirements. The standard can be implemented by the industry to establish, implement, maintain, and improve quality management systems, ensure conformity with customer and regulatory requirements, demonstrate conformity with ISO 13485:2016, and validate processes. Punyam.com offers ISO 13485 certification consultancy services.
Source Link: https://www.punyam.com/services/iso-13485-certification-consultancy/
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