ISO 14971 & IEC 60601 Training Program

ISO 14971 – Medical Devices – Application of Risk Management to Medical Devices Training

Course Agenda:

• Introduction to Risk Management
• Overview of the ISO14971 and ISO TR 24971 changes
• Walk through on the clauses of ISO14971:2019
• Walk through on the clauses of ISO/TR 24971:2020
• GHTF/SG3 guidance document

IEC 60601 - Electrical Safety - General Requirements Training

Course agenda :

• Legal basis
• Requirements - Electrical Safety [EN/IEC 60601-1]
• Possible evaluation by certification body / Notified Body on Conformity Assessment Process of 13485/MDD/MDR

Course Content : The course material (standard + slides) will be provided as a part of the program.

Mode of Delivery : Live eLeanring - Online

Training Hours : Training hours could be customised as per client needs.

Certification: Training Certificate would be provided jointly with our Training partner Cliniminds.