Wednesday, 15. September 2021 | 10:40 - 10:50

Hall 2: Innovation Symposium

Program Entry

Medtech innovations & new regulatory challenges

Full product lifecycle support from Design to Post Market Medical Devices, Combined Devices, SAMDs. How support new regulatory challenges with planning of smooth transitions.

In PLG we are taking care of correct planning smooth transitions capturing new Regulatory challenges, thanks to cross functional expertise in regulatory, safety, and quality, information management, in both Medical devices and In vitro Diagnostic PLG develops pragmatic strategies consulting.

 

Innovation in the new regulatory framework of EU MDR and IVDR :

  • How to address all new obligations of innovative solutions during the entire product lifecycle for 
    • Digital Medical device solutions ( Digital Health , IA )
    • Software As Medical device as stand-alone or embedded
    • MDSW and monitoring devices 
  • Innovation trends in the MEdical device market and IVD from regulatory and compliance solution.

 

New Regulatory Challenges: 

  • EU MDR , how to address all new requirements of Medical Device Regulation with a correct Regulatory and quality strategy in compliance with harmonized standards.
  • EU IVDR how to address all new requirements of In-vitro Diagnostic  Regulation with a correct Regulatory and quality strategy in compliance with harmonized standards.
  • Brexit, new requirements of MHRA 2002 regulation, how to address UK Responsible person, UKCA and UKNI compliance pathways
  • MRA not renewed, how to get in front on the EU and UK scenarios,
  • which are the obligations to comply with for a Swiss Manufacturer, Importer, Distributor in EU,
  • which are the obligations to comply with for a Foreign Manufacturer to place the product into the Swiss Market (Swiss Representative) 

 

 

 

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