Regulatory essentials in health tech – training series part II

Do you need more information on regulatory essentials in health tech? Business Oulu / OuluHealth in cooperation with Lean Entries is offering Oulu-based companies / innovators a continuation of training series related to this topic.

The training package consists of three parts that will be held as webinars on 9.6, 16.6. and 23.6.

Why attend?

The material presented during the series of webinars will take you further into practical knowledge on Clinical Evaluation, Post-Market Surveillance and Risk Management, and how they are harnessed for patient safety, efficacy and business needs. These processes represent the regulatory cornerstones for placing your technology on the global health care market.

What is the cost?

These trainings are free of charge.

Who are the coaches?

The sessions will be organized as part of the 6Aika – Kasvun ekosysteemit –project and they will be run by the Lean Entries team of experienced medical device regulatory professionals Ilona Santavaara, Leena Raunio and Heikki Pitkänen.


1. Clinical Evaluation in Practice, trainer Ilona Santavaara.
Time: 9.6.2020, 12.00-15.00  
– Purpose of Clinical Evaluation
– MDR requirements and guidelines
– Structure of Clinical Evaluation Plan and Report
– Claims and clinical benefits of your device
– Establishing “state of the art”
– Gathering and assessing clinical data
– Conducting and documenting literature and database searches

2. Post-Market Surveillance and Post-Market Clinical Follow-up, trainer Heikki Pitkänen or Ilona Santavaara
Time: 16.6.2020, 12:00-15:00 
– 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)

3. Risk Management in practice, trainer Leena Raunio
Time: 23.6.2020, 12.00-15.00
– Purpose of Risk Management
– MDR requirements and ISO 14971 standard
– Fundamental concepts
– Stages of Risk Management process
– Risk analysis, evaluation and control in practice
– Residual risks and Risk Management Report
– Risk Management throughout the product life cycle

Please register for the trainings to get the participation link:

Contact person

Salla Hirvonen
040 726 1842



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