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    Regulatory Essentials in Health Tech: Early Development and Management

    REGULATORY ESSENTIALS

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

    The Regulatory Essentials in Health Tech training series consists of 14 1,5-2 hour on-demand webinar sessions.
    Read more on the complete course page here >>

    Topics 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
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    Trainers

    Heikki Pitkänen
    Heikki Pitkänen
    CEO & Founder, Lean Entries - Senior Expert, Regulations & Quality
    heikki.pitkanen@aurevia.com
    ”I have more than 20 years of experience in 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."

    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 the medical device or in vitro diagnostic regulations. Particular 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 of the medical device life cycle from early development to post-market actions
    • Know what to consider when planning your Quality Management System (QMS)

    Notice

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

    What next?

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    Regulatory Essentials in Health Tech - Full Training Series
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    Billing and cancellation policy

    Read the billing and cancellation policy for online trainings here.

    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@aurevia.com.  
    The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to:  koulutus@aurevia.com. 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.