Regulatory Essentials in Health Tech – Session 4 Design Control and the Regulatory Environment

This session reviews the principles of Design Control, starting from feasibility studies and all the way to post-market surveillance. A brief look on roles of key authorities, overlooking devices and manufacturers, is also given.

The Regulatory Essentials in Health Tech training series consists of eleven 2,5h webinar sessions.
Read more on the complete course here.

Time: 14.9. 2021, at 10.00-12.30
Place: Teams
Price: single session 250€ (Prices are VAT 0%)

 

 

Target Group: All health tech developers and stakeholders interested in gaining crucial knowledge on how to save months in time-to-market of health tech innovations and to avoid typical dead-ends due to non-compliance to medical device or in vitro diagnostic regulations. Special focus on start-up founders and staff, university innovator teams and young health tech professionals, business advisors and investors from early seed development to international scaling.

After this session, you:

  • Know-how to control the design according to the global requirements throughout the device life cycle
  • Understand the changing regulatory landscape, the mindset of the authorities and the market access mechanisms in major markets globally

Notice: It is recommended to combine this session with the Regulatory Essentials sessions 1, 2 and 3.

Kouluttaja:

CONTENT OF THIS SESSION:

    • Introduction to Design Control
      • From Feasibility Studies to Post-Market Surveillance
      • Design Verification and Validation
      • Transfer to production
    • Authorities, Notified Bodies and test labs
      • Towards certification – CE-mark, FDA approval and global market access
      • The perspective of authorities globally
      • Auditing and certification practices
      • Communicating with the authorities
    • Considerations on the Changing Global Regulations
      • Navigating the transitional periods
      • From the current EU directives to new regulations – MDR & IVDR
      • Strategies for dealing with a variety of requirements and timelines

BILLING AND CANCELLATION POLICY 
Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.

Cancellations are always made in writing to: koulutus@labquality.fi.  
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: koulutus@labquality.fi. The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event.  Labquality reserves the right to cancel the training session due to a small number of participants.

Pin It on Pinterest

Jaa sivu