This course is designed to provide you with knowledge of how the Medical Device Regulation (MDR (EU 2017/745)), standards and guidance documents impact medical device software; software as a medical device; and medical devices with software.
It will help you to understand how EN 62304 Medical device software - software lifecycle processes can improve your medical device software development, validation and lifecycle process.
Prerequisites
You should have an awareness of Medical Device Regulations and knowledge of medical device software to benefit from this course.
Pedagogical objectives
- Understand the key concepts and requirements of EN 62304
- Gain knowledge of the implementation steps of the medical device software lifecycle processes
- Correctly classify your medical device software as per the MDR
- Perform the necessary risk management and software lifecycle management activities
Skills to be acquired
On completion of this training, you’ll be able to:
- Define the medical device software terminology
- Identify the relevant standards, directives, and guidance documents
recommended to develop, maintain and validate medical device software - Determine if software is covered by an EU Medical Regulation for CE
Marking - Classify your medical software as per the MDR
- Apply concepts from the key software standards; including EN 62304
(Medical device software - Software lifecycle processes), EN 60601-1
(Medical Electrical Equipment and Systems) and from the MDR EU
2017/745 - Evaluate software lifecycle processes and risk management to ensure they are compliant
Targeted audience
This course is intended for individuals or organizations involved in software within the medical device industry.
Pedagogical objectives
Course materials including:
- Introduction to the training, detailed program and security assignments
- Course presentation, theory and activities/role plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signed
Assessment specifics
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
What is included?
- Course materials, provided electronically
- Letter of attestation
- Official certificate
Do you need more information?
If you have any concerns, please do not hesitate to contact our service department on the following numbers:
Telephone: 01 89 79 00 40
Email: training.france@bsigroup.com Or via the webchat service on our website: bsigroup.com
You will be put in touch with our team if necessary.
