This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.
Why should you Attend:
Many companies have even experienced class action law suits because of product quality issues. An effective program of risk management can help you proactively identify and mitigate product risks.
Areas Covered in the Session:
Overview of the ISO14971 standard as it applies to medical device companies
Integrating the new standard with ISO 13485 as part of your overall QMS
Conducting a review of the intended use of your device
Stages of Risk Management as well as Tools and Techniques
Judging the probability that harm may occur from those hazards
Who Will Benefit:
R&D Project Managers
Regulatory Affairs Specialist
Susanne Manz MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.
Compliance4All DBA NetZealous,
Email: [email protected]