WEBINAR: Understanding the Regulatory Landscape for Medical Devices and Diagnostics
iiCON: the Infection Innovation Consortium in collaboration with iiDiagnostics and QMS Consultancy are delighted to invite you to an online session.
- WHAT: Understanding the Regulatory Landscape for Medical Devices and Diagnostics
- WHEN: March 10th 12pm to 2pm
- WHERE: Virtual Session (Teams)
Open to business, researchers and entrepreneurs, this lunchtime online workshop is designed to give you a detailed understanding of navigating the medical device regulatory environment and the skills and services available at iiDiagnostics and QMS Consultancy.
iiCON: the Infection Innovation Consortium recognise that the transition from the In Vitro Diagnostics Directive ( IVDD) to the more stringent In Vitro Diagnostics Regulation (IVDR) and the conformity deadline of May 2022 is raising questions regarding how to update technical documentation to meet the new more stringent regulations. Join us to discuss how industry can efficiently transition their regulatory processes and move towards compliance.
The first hour, delivered by Richard Hall from QMS will focus on understanding these new rules and the tools to accelerate your route to market and meet your regulatory goals.
- Is your technology a medical device?
- When does software become a medical device?
- What classification is my product?
- What impact will the new regulations have on my device and my company?
- What is the purpose of a Quality Management System
- What do I need to do to get to market?
- What is the purpose of a Quality Management System ?
- What is ISO 13485 and how do you gain certification?
The second part of the session will give you an introduction to the diagnostics expertise within iiDiagnostics, a spin-out company from Liverpool School of Tropical Medicine.
- Skills and services available to companies
- Case studies of supporting route to market
This session is supported by the Bloomsbury SET and the Wellcome Trust Institutional Translational Partnership Award with the objective of increasing translational activity and impact. We look forward to welcoming you to a very informative session.