ISO 14971:2019 Risk Management 


Course Overview


Our 2 day ISO 14971:2019 Risk Management training course focuses on the application of various risk management tools to meet the requirements of the harmonised standard ISO 14971:2019. 

ISO 13485:2016 requires medical device manufactures to implement a Quality Management System that has a greater emphasis on risk. This course for medical device manufactures has been developed to meet this more rigorous focus on risk management.

Our expert tutors will provide you with an in-depth understanding of ISO 14971:2019 in addition to comparing ISO 14971:2019 with the requirements of the EU Medical Device Regulation (MDR) 2017/745. 

Course Agenda

▪   Risk definitions

▪   What standard?

▪   ISO 14971

▪   ISO 14971 2012 vs 2019

▪   TR 24971

▪   Annex Z deviations 

▪   Risk and the MDD/MDR

▪   Links to other processes

▪   Risks and other standards

Day 1: 8:30am - 16:30pm

Day 2: 9:00am - 16:30pm

The certification you will earn can be used to demonstrate your knowledge to your employers and Notified Bodies.

Learning Style

This is a classroom based course filled with practical and interactive activities to embed your learning. 

Business Meeting

Who should attend?

This ISO 14971 training course has great value for anyone involved in implementing or maintaining a QMS. 

▪    Quality Assurance professionals

▪    Quality Engineers

▪    Research and Design Engineers

▪    Internal Auditors

▪    Quality Managers

▪    Manufacturing Engineers

▪    Regulatory professionals

What will I receive?

▪    Lunch

▪    Refreshments 

▪    Training course notes, slides and handouts 

▪    Risk Management training course certificate 

Our team Is on hand to support you with any B&B bookings if required. 

On-site Training

Any of our courses can be delivered on-site at your premises. 

Contact us today to find out more.