Regulatory Essentials in Health Tech – Session 2: Early Development and Management


This session wraps up the must-know issues to consider in the early development of your innovation. How to demonstrate compliance to applicable regulation and how to build up a Quality Management System (QMS) which ensures that devices consistently meet the requirements for safety and performance?

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: 22.3.2022 at 10.00-12.30 (EET)
Place: Online
Price: 250€ + VAT 24%

AUTUMN 2022
Time: 1.9.2022
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, young health tech professionals, business advisors and investors from early seed development to international scaling.

After this session, you:

  • Know what to take into account regarding regulations and standards from the early stage of product development
  • Have a view on the medical device life cycle from early development to post-market actions
  • Know what to consider when planning your Quality Management System (QMS)

Notice:
It is recommended to combine this session with the Regulatory Essentials sessions 1, 3 and 4. For more specific knowledge and hands-on approach to ISO 13485 and QMS requirements it is recommended to follow a one day ISO 13485 -course.

Trainer:


Heikki:
”I have more than 20 years of experience from the health tech field including responsibilities in product development as well as regulatory and quality related positions. I have worked previously at SGS as a site manager providing Medical Device manufacturers with Notified Body, accredited test lab and training services for worldwide market access. I have participated in international standardization and in the CEN-CENELEC Advisory Board for Healthcare Standards.
I´m the CEO and founder of Lean Entries Ltd, which is a part of the Labquality family of companies. Lean Entries provides the Entries platform with digital regulatory runway services, as well as training on the regulatory essentials, to organisations from health tech startups and universities to multinational manufacturers.”

CONTENT OF THIS SESSION:

    • Early development stages
      • Timelines and the Medical Device Life Cycle
      • Capturing the Value Proposition
      • Early validation through Feasibility Studies
      • Preparing for Design Control and Post-Market activities
      • Assigning roles and responsibilities in-house and externally
      • Document and records management, logs and traceability
    • Building your Quality Management System (QMS)
      • ISO 13485 and other international QMS related standards
      • Management responsibility
      • From planning to operations – Ensuring consistently safe and efficient devices
      • Supplier Control – From supplier evaluation to contracts and partnership
      • Importer and Distributor relations

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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