Ensuring Medical Devices are safe and [Effective] for Intended Uses

Overview:

You'll learn techniques that can help you identify hazards and potential harms. You'll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products.

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. A good risk management process can help you methodically identify, mitigate, and monitor risk throughout the product life-cycle.

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.

Who Will Benefit:

Design Engineer

Manufacturing Engineer

Quality Engineer

R&D Personnel

Event Fee: One Dial-in One Attendee Price: US $150.00

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com

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.