Course description
Gain an understanding of the medical device software lifecycle processes, classification rules and development activities to meet regulatory requirements.
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.
Upcoming start dates
Suitability - Who should attend?
This course is intended for individuals or organizations involved in software within the medical device industry.
Pre-requisites
You should have an awareness of Medical Device Regulations and some basic knowledge of medical device software to benefit from this course.
Outcome / Qualification etc.
This course will help you to:
- 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
Training Course Content
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
Course delivery details
- You will gain 8 CPD points on completing the course
- You will be awarded an internationally recognized BSI Training Academy certificate
- Training course notes
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