Regulatory Essentials in Health Tech – Session 11 Post-Market Surveillance & Post-Market Clinical Follow-up

This session gives a basic understanding of regulation to Post-Market Surveillance (PMS) and the mandatory PMS documentation, such as Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP).

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

Time: 7.10. 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 specific knowledge on how to take into consideration the Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) requirements for medical devices and in vitro diagnostics to remain in compliance throughout the device life-cycle. Special focus on start-up founders and staff, university innovator teams as well as young health tech professionals and new employees.

After this session, you:

  • Understand what are the fundamental requirements for Post-Market Surveillance for all types of medical devices
  • Understand the relationship of Post-Market Surveillance to Clinical Evaluation, Risk Management and business in long term

Notice: It is recommended to follow the Regulatory Essentials sessions 1-4 as well as the session 7 (Risk Management) and 10 (Clinical Evaluation) prior to this course.

Kouluttaja:

CONTENT OF THIS SESSION:

    • Purpose and definitions of PMS and PMCF
    • MDR requirements and guidelines
    • How to gather data and identify data gaps
    • PMS process and plan
    • Trend reporting
    • When and why to conduct a PMCF study
    • PMS and PMCF in relation to Clinical Evaluation
    • PMS report, Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP)

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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