CE Marking Medical Devices with Software Training
The steps you take to define, classify, develop, and test your software is critical to both your business and patient health when it applies to a medical device.
Achieving and maintaining a CE mark for your medical device software therefore becomes essential to keeping your product marketable.
This course will help you learn how the medical device directives apply to your software, how your software is classified, and how to develop and maintain it with a CE mark in mind. You will learn how to evaluate your software and processes so you’ll know what to do during the software life-cycle to meet the medical device directives.
Who should attend?
This course is delivered in-house and recommended for:
- Medical Device Product managers
- Medical Device Product designers
- Medical Device Product testers
- Medical Device Software Product developers
- Medical Device Quality managers
- Medical Device Quality engineers
- Medical Device Regulatory personnel
Learn how to achieve and maintain a CE mark for your medical device software
What will I learn?
- How to identify the relevant directives, standards, and guidance documents recommended to develop, maintain, and validate medical software according to the state of the art
- How to determine if your software is covered by an EU medical directive for CE Marking, and if so how you can classify it
- How to apply concepts from the key software standards and guidance documents, including BS EN 62304, MEDDEV 2.1/6, and BS EN 60601-1
To develop the basic knowledge necessary to evaluate software lifecycle processes and risk management to ensure that they are compliant with the medical directives
How will my company benefit?
- Your business will be able to meet the medical device directive requirements that apply to validating medical software according to the state of the art
- Your company will be able to properly classify medical products with software based on medical device directive requirements and the latest guidance documents
- Your organization can plan more effectively software risk management, development, testing, configuration management, maintenance and problem resolution
- It will be able to achieve a CE mark for medical devices containing software more efficiently
- And your business will be able to assess risks that may impact on its medical software development
- You will gain 8 CPD points on completing the course
- This course is delivered in-house
- Course Notes
- Certificate of attendance