Is your Medical Device Software ready for MDR?
The Medical Device Regulation (MDR) is fully applicable since May 26th 2021.
Although the MDR transitional provision has been extended* there is no time to lose for Medical Device Software manufacturers (MDSW) to be compliant with MDR since only then it is possible to continue updating and improving your software the way you want to (without considering the restrictions of MDR article 120).
We have the perfect package deal that will keep you ahead of the game and compliant with the requirements.
Do you feel confused about your next steps?
Don’t worry, we can help you through the process. Our team of specialists have extensive knowledge in all aspects of the development of medical devices. We can help you to get ready and to get your software compliant before the time runs out.
Here is what you will get out of this tailor-made package for MDSW manufacturers:
MDR and MDSW training
- Basic understanding of the regulatory requirements on medical device software (MDSW)
- Qualification and classification of MDSW
- Useful standards and guidelines
- Software safety classification according to IEC 62304
GAP Analysis
We perform a GAP analysis of your current QMS and technical documentation to identify possible gaps to be addressed to be MDR compliant.
Workshops
Tailored for your specific needs. For example:
- Document walk-through and update
- Process walk-through and update
- SW risk management
Price: 99 000 SEK
To ensure that your Medical Device Software is MDR compliant we recommend you to:
- Update or create your QMS
- Update or create your technical documentation
- Create a submission to a suitable notified body to CE-register your software
Webinar - Fusion of AI and Medical Devices
Watch the recording now to stay ahead of AI compliance challenges!
Key topics include:
- How AI-based MDSW differs from traditional software in regulatory reviews
- The biggest challenges Notified Bodies face in assessing AI medical devices
- Strategies to engage Notified Bodies early and avoid approval delays
- Why AI transparency & explainability are critical for regulatory success
