Medical Devices for Risk Management Techniques 2017

Overview:
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 Profile:
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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

Others Details

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