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


Medical Devices Software
20 Oct 2021
74
About us
#Webinar

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).

Did you find this article useful? Share it on social media.

Need expert advice from our consultants?

Articles

CN Group

CN Group CZ a.s.
Prague Office 
Ve Smečkách 20 
110 00 Prague 1 
Czech Republic
Registration No.:
07885041

Locations
Contacts
Social Media
LinkedIn
Twitter
Xing
Facebook
YouTube
Instagram
Reviews on Clutch
clutch logo
© 2020-2022 CN Group CZ a.s., All rights reserved.
  • Sitemap
  • Legal Terms / Impressum
  • GDPR
  • Risk and Compliance