ISO 13485 Certification Consultant - Ahmedabad

ISO 13485:2016 Medical Devices - Quality Management System Requirements is a document that mandates medical device manufacturers to incorporate quality management system requirements into their management systems. It replaces ISO 9001's emphasis on continuous improvement and customer satisfaction with a focus on meeting regulatory and customer requirements, risk management, and maintaining effective processes. ISO 13485 certification aligns an organization's management system with the FDA's Quality System Regulation (QSR) requirements and other global regulatory requirements. Punyam.com offers ISO 13485 Certification consultancy services. The certificate is issued for three years after successful completion of pre-assessment and registration assessment, and is valid until the certificate expires.

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