Is your Medical Device Software ready for MDR?
The clock is ticking for MDR.
The Medical Device Regulation (MDR) is fully applicable since May 26th 2021, and no later then May 26th 2024, all Medical Device software must be compliant with MDR.
Do you feel stressed about the deadline?
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.
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
