ISO 14971 Medical Device Risk Management

Manage risk effectively and see business success with our ISO 14971 Medical Risk Management Training Course – an essential and international accreditation for all medical device manufacturers.

The ISO 14971 standard outlines how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle and we can help you implement a risk management framework to achieve ongoing compliance.

“The delegates were given freedom to discuss their own experiences and the tutor related these experiences to the course.”

Our course is delivered by professionals with unrivalled practical experience and designed to help you get to grips with ISO 14971. In just one day you will understand how the standard can improve risk management within your business, as well as drawing links with quality management standard ISO 13485:2003 – focussing on 2007 changes. You will take away the tools to confidently manage risk to an international standard.

Learning objectives

• Understand the importance and purpose of ISO 13485
• Identify the links between ISO 13485 and ISO 14971
• Learn how risk management applies to the product lifecycle
• Define risk management terminology and objectives
• Outline and lead the ISO 13485 risk management process
• Gain CPD points and professional recognition.

Benefits of attending this course?

• Be confident your medical devices are ISO 13485 compliant
• Ensure compliance continues throughout product lifecycle
• Gain competitive advantage with ISO 13485 accreditation
• Increase market access and customer confidence 
• Encourage professional development and build risk awareness.

BSI In-Company (In-House) Training Option gives you:

• Onsite delivery
We come to you: Save money. Avoid travel and accommodation expenses.
• Training designed for you
Based on your needs, we can build the course to help you achieve your specific objectives.
• More for less
Include team members cost-effectively with BSI In-Company training.

Contact us for a customised quote today.