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Introduction

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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Venue

Hilton Irvine Orange County

Hilton Irvine Orange County, 18800 MacArthur Blvd Irvine, Irvine/California, 92612, United States

Organised by

ComplianceOnline

Contact information

Mr admin
Palo Alto, 94303, United States of America
650-620-3915
Contact us by email

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