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Regulatory Essentials in Health Tech: Post-Market Surveillance and Clinical Follow-up

Home / Trainings and events / Regulatory Essentials in Health Tech: Post-Market Surveillance and Clinical Follow-up

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

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

  • 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)
Register

Trainers

Heikki Pitkänen
Heikki Pitkänen
CEO & Founder, Lean Entries - Senior Expert, Regulations & Quality
heikki.pitkanen@labquality.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 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 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 the long term.

Notice

It is recommended to follow the Regulatory Essentials sessions 1-4 as well as sessions 8 (Risk Management) and 11 (Clinical Evaluation) before this on-demand session.

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@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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