Navigating the regulatory pathways for Digital Health products and services can be complex. This essential webinar will explore all the main identified regulatory frameworks required for the deployment of digital solutions into the UK, EU and US markets.


 

Any digital solutions being provided by new software or medical devices associated with healthcare delivery will be accompanied by strong regulatory requirements. It is essential that your company understands and implements the main regulatory frameworks at all stages of your product's life cycle. 


The session will cover:

  • Regulatory frameworks in the UK, EU and US
  • Digital Therapeutics 
  • Telemedicine and the solutions which need to be supported by validated medical device solutions
  • Innovative wearable technologies for healthcare. These can be seen as either digital therapeutics, telemedicine or as stand-alone devices so choosing the correct option for your product is essential
  • How the Covid-19 experience has changed the framework for medical devices for example MHRA Target Product Profiles (TTP) and FDA Emergency Use.

 

Speakers

  • Paolo Guerra, Medtech Director of Medical Devices Delivery and IVD Services, ProductLife Group
    • With over 7 years of regulatory experience in regulations, Paolo is currently responsible for device vigilance, CE marking and quality assurance across all regulated stages of the product life cycle, from development, to launch to post-marketing. 
  • Dr Ahmed Bouzidi, Vice President of Biotech Strategic Development, ProductLife Group
    • Dr Boudzidi has served as President of EBE-Biopharma and is a board member of Vaccines Europe and a Senior Associate at the Royal Society of Medicine.  Having held senior advisory positions with Chinese pharmaceutical companies and public institutions, Dr Bouzidi currently supports biopharmaceutical companies tackle current and future healthcare challenges.