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 all the way to Post-Market Surveillance. A brief look at the roles of the key authorities, certifiers and test laboratories overlooking devices and manufacturers is also given.

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


 

SPRING 2022
Time: 29.3.2022 at 10.00-12.30 (EET)
Place: Online
Price: 250€ + VAT 24%

AUTUMN 2022
Time: 8.9.2022
Place: Online
Price: 250€ + VAT 24%

 

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.

Trainer:


Karri:
”I have more than twenty years of experience from the Medical Device industry in various positions, with responsibilities for leading a quality assurance team and overall regulatory compliance according to the ISO 13485 standard, Brazilian (ANVISA), Australian (TGA), US FDA and the EU MDR requirements. I have also worked in the Management Representative role for various companies and most recently as a Person Responsible for Regulatory Compliance (PRRC).

My responsibilities have also spanned design and development of new Medical Devices, their immaterial property rights (IPR) and supply management. I have worked in start-ups and growth companies for most of his career, holding also the role of a co-founder, which has provided me with a wide perspective into the challenges that young companies face on their way to the international market.”

 

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.

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