Risk Management of Medical Devices is a critical aspect to ensuring that medical devices are designed to be safe and effective, thus demonstrating compliance with the various Medical Device Regulations / Directives around the world.

Risk Management of Medical Devices is a critical aspect to ensuring that medical devices are designed to be safe and effective, thus demonstrating compliance with the various Medical Device Regulations / Directives around the world.

ISO 14971 has been the standard of choice for many years and in 2012 the European version of the standard (EN 14971:2012) was released that better highlighted how this standard could be used to gain compliance with the Medical Device Directives of Europe.

Although the basic premise for compliance has not changed, there are some important areas of the standard and it’s application that may not have been detected.

Day 1 is the introduction to the standard and the principles of risk management. Day 2 is a workshop based application of the standard. Delegates are invited to attend both days or just one of the two days.

Course Content – Day 1

• Introduction to Risk Management standard(s)

• Introduction to Risk Management principle(s)

• Regulatory context of risk management

• Relationship to the medical directives and IEC 60601-1 3rd edition

• Management commitment to the risk management process

• Risk analysis

• Risk evaluation

• Risk control

• Residual risk evaluation

• Risk management report

• Keeping the risk management file(s) up to date as a result of changes

This course is a hand on approach to the EN ISO 14971:2012 risk management standard.

Participant Profile

This is an entry level course and the target audience is for people who are involved in risk management of medical devices.

Typical attendees include:

Regulatory Affairs personnel

Quality Assurance and Control personnel

Project and design engineers

Benefits of Attending 

Delegates will come away with an understanding of how the risk management standard (14971) can be implemented within their organisation to ensure current and future regulatory requirements are met.

Trainer Profile 

Jeff Vest is the Manager of the Medical Device Group in the TÜV SÜD UK office. He has been conducting technical documentation reviews and regulatory audits to ISO 9001,13485, EN 4600x since 1999 covering the requirements for Europe, Canada, Japan. Risk Analysis and Risk Management has been at the heart of each of these audits and technical documentation reviews.

Course Cost: €495 pp 1 day

Duration: 1 day

Date: 26th September

Location: Galway or Dublin

This course is available as an on-site customised course

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