Medicom Consulting

An intensive two-day training course on how to establish and improve compliance with the GMP requirements for risk management

Background

Compliance to the Medical Devices Directive (93/42/EEC, 2007/47/EC), in vitro Diagnostic Medical Devices Directive (98/79/EC), FDA Quality System Regulation, 21 CFR Part 820, and ISO 13485:2003 require medical device risk analyses to be conducted, implemented and maintained.
ISO 14971:2007 Medical Devices – Application of Risk Management to Medical Devices provides the details to achieve compliance.
Notified Bodies are increasingly raising non conformances against manufacturers who do not conduct and maintain risk management throughout the lifecycle of medical devices.

Learning Objectives

The course provides an opportunity to:

• To understand the regulatory requirements for conducting risk analysis and risk management.
• Fully understand the requirements of ISO 14971:2007 and its interaction with ISO 13485:2003 Medical Devices – Quality Management Systems.
• Learn the process and different approaches for conducting a medical device risk analysis.
• Understand the requirements for conducting risk management throughout the quality management system, using guidance provided by the GHTF (Global Harmonisation Task Force).
• Learn the key elements that Notified Bodies look for in quality system risk management.
• Review the changes between ISO14971:2000 and the latest published standard ISO14971:2007.

Course Details

The course presents the risk management requirements comprehensively, and uses interactive sessions as well as formal presentations. Each delegate is provided with a course manual containing comprehensive notes on topics presented, and copies of relevant regulations and guidance documents are provided for the use of delegates during the course. 
Delegates receive a "Certificate of Successful Completion” or "Certificate of Attendance”

Contact us for detailed training agenda and prices