Medical Devices 2011 - Integrating a Quality Management System and Risk Management for Medical Devices

Course Description
Medical device manufacturers implement a Quality Management System (QMS) as part of the regulatory requirements. For products marketed in the EU and Canada, manufacturers use ISO 13485. For products marketed in the US, the requirement is FDA QSR. Both systems stem from ISO 9001 concepts. A critical element of medical device quality is Risk Management. The basic standard is ISO 14971.

This 2 days ComplianceOnline seminar covers the essential elements of a medical device quality management system involved in creating an effective Risk Management system. Using ISO 13485 as a model, the seminar covers the QMS essentials that have the most direct impact on Risk Management. These QMS activities include product planning, design and development, supplier management, process validation, customer complaints, internal quality audits, corrective action, preventive action, and post-market surveillance. In addition, the seminar clarifies the requirements for verification and validation. The material compares and contrasts ISO 13485 and FDA QSR requirements.

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