Risk Management for Medical Devices
Our 2 day instructor-led ISO 14971:2019 Risk Management 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.
Unlike many other online trainings, we encourage you to bring and ask as many questions as you like! This is the best way to embed your knowledge and gain a thorough understanding. We are here to help you make your medical devices compliant.
This course is fully interactive and offers you the chance to take part in group activities, participate in polls and share and download course materials.
▪ Introduction to ISO 14971:2019
▪ Regulation and the Z-Annexes
▪ The procedure and plan
▪ FMEAs and fault trees
▪ Application to ISO 13485
Understand the relationship with other standards:
▪ The 60601/61010 series
▪ Usability (EN 62366)
▪ Biocompatibility (ISO 10993)
You have the opportunity to ask as many questions as you like to our expert trainers throughout the course.
Day 1: 8:30am - 16:30pm
Day 2: 9:00am - 16:30pm
Due to the nature of the course, an exact time of each topic can not be provided.
The certification you will earn can be used to demonstrate your knowledge to your employers and Notified Bodies.
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?
▪ PDF training course notes, slides and handouts
▪ The opportunity to get your questions answered!
▪ Full tutor support