Medical Devices for Risk Management Techniques 2017

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:

Design Engineer
Manufacturing Engineer
Quality Engineer
R&D Personnel
R&D Project Managers
Quality Managers
Auditors
Regulatory Affairs Specialist
R&D Manager

Speaker and Presenter Information

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.