Webinar on developing Medical Device Software co-hosted by CN Group

Medical Devices Software
20 Oct 2021
About us

CN Group and Drug Development & Regulation (DDR) co-organised an informative session on development and Regulation of Medical Device Software (MDSW). The webinar covered the main considerations to keep in mind when developing a MDSW under the new Medical Devices Regulation (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 developers of Medical Devices Software (MDSW). The recent, but considerable, emergence of MDSW led to their being integration into the new regulations, and  significant changes in their development, classification and registration.

During this webinar, CN Group and DDR (Drug Development & Regulation) first defined the main stages of device development - from original idea to regulatory strategy – needed to correctly develop Medical Device Software (MDSW) under the new MDR. Moreover, the speakers discussed in detail two case studies on existing MDSWs to further illustrate all the concepts considered during the session.

At the end of the presentation, during a 15min Q&A session, participants had the opportunity to ask questions and share their 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).

About Drug Development & Regulation (DDR)

DDR is an independent regulatory consultancy company, focused on providing appropriate scientific & regulatory expertise for the global development and registration of Drugs and Medical Technologies. DDR identifies fast and cost-efficient strategies to get products successfully authorised by Regulatory Agencies (quality, nonclinical, clinical & regulatory expertise).

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