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Veristat (formerly DDR) and partner CN Group co-organized an informative session on the development and Regulation of Medical Device Software (MDSW). The live webinar was held on 14 October 2021 and covered the main considerations to keep in mind when developing a MDSW under the new Medical Devices Regulation (MDR).
Watch the replay HERE
You will be redirected to the DDR YouTube Page to View The Webinar Replay.
More About The Webinar
Development and Regulation of Medical Device Software under MDR
If the implementation of the new European Medical Devices and In Vitro Devices Regulations (respectively MDR and IVDR) is complex for most device manufacturers, it is particularly challenging for Medical Devices Software (MDSW) developers. The recent but considerable emergence of MDSW led to their integration into the new regulations, implying significant changes in their development, classification, and registration.
During this webinar, CN Group and DDR (now Veristat) will first define the main stages of device development, from idea to regulatory strategy, to properly develop a Medical Device Software (MDSW) under the new MDR. Moreover, the speakers will discuss in detail two case studies on existing MDSWs to further illustrate all the concepts developed during the session.
At the end of the presentation, you will have the opportunity to ask your questions and share you thoughts directly with the main speakers Milan Piskla (.NET / CAD / C++ Technology Director, CN Group), Andrea Larrañaga (Regulatory Manager, DDR) and Laura Ocaña (Regulatory Officer, DDR) during a 15min Q&A session.
Total duration 1 hour – Orginal Webinar Held on October 14th, 2021 – 04PM CET/03PM BST/10AM EDT
About CN Group (Czech Republic, Slovak Republic, Romania)
For over 27 years, CN Group has been providing high-quality IT Software Development and Consulting services to their partners in Scandinavia, Germany, Austria, Switzerland, and the UK. Throughout their quarter-century history, CN Group guiding principle has been Continuous Improvement. The Group knowledge, experience, skills, and services extend far beyond the technologies implemented.
More information: fazik@cngroup.dk | www.cngroup.dk
More About Veristat
- Medical Device and IVD Regulatory Support
- End-to-End Regulatory Affairs, Consulting, and Operations Overview
- Full Clinical Development Solutions