Medical Device Software and new Medical Device Regulation
Long-awaited moment finally happened last week, as after a one-year delay the European Union's new Medical Device Regulation (MDR) came into force last Wednesday. We at Innokas Medical are well-prepared for the MDR internally; as an example, our Quality Management System has been updated to ensure the compliance with the new regulatory requirements. Additionally, our entire QA/RA team knows MDR requirements well and we’re involved in various networks influencing the practical implementation and interpretation of MDR requirements.
Are your company's quality management system and products still far away from MDR / IVDR compliance? Get in touch with us; in addition to the internal development work, we offer regulatory support and guidance to help our customers to master their MDR / IVDR compliance. Please read more information from our QA/RA Services site and fill out the contact form to reach us!
Ask also if you are interested to solve practical software development challenges and deployment of the compliant process in daily use.
Original text: https://blog.innokasmedical.fi/blog/mdr-is-here
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