ISO 13485: Medical Devices QMS - Requirements for Regulatory Purposes

On-Demand – 2 hours

Course Overview

This two-hour course provides in-depth instruction and expert clarification of ISO 13485:2016, the standard that serves as a basis for many medical device QMS regulations around the globe. This course covers the goals of the standard and detailed information on Clause 4-QMS, Clause 5-Management Responsibility, Clause 6-Resource Management, Clause 7-Product Realization and Clause 8-Measurement Analysis and Improvement.

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Additional Recommended Courses

Medical Device Single Audit Program (MDSAP)

This virtual instructor-led one-day course covers the rationale for developing the Medical Device Single Audit Program (MDSAP), who the participating regulatory authorities are, and the specific audit criteria (including country-specific requirements) used during MDSAP audits.

This course discusses, in depth, the audit approach used by recognized MDSAP auditing organizations (AOs) as well as the MDSAP nonconformity grading system. Learners will also identify what MDSAP audit findings may trigger action from a participating regulatory authority.

This course pairs well as a prerequisite to MDSAP Internal Auditor Training (2 day).

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

Discuss the Medical Device Single Audit Program (MDSAP)
Evaluate the MDSAP Quality Management System (QMS) audit nonconformity grading system and recognize grades that may trigger regulatory follow-up
Identify the IMDRF MDSAP requirements and documents in use
Explain the MDSAP Audit Approach

Price: $800.00