ISO 14971:2019 Risk Management
Our two 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.
▪ 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)
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?
▪ Training course notes
▪ ISO 14971 Risk Management training course certificate