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Health Tech Regulations, Quality Management and Commercialization

Home / Trainings and events / Health Tech Regulations, Quality Management and Commercialization

This is a health tech regulation, quality management and commercialization training for R2Bs and startups. The commercialization of innovations is always a challenge, but it is especially a challenge when the product is strictly regulated, as in the health technology sector. Come and hear the basics of quality management systems and the commercialization of medical devices. In addition to the training day, you will receive 60 minutes of personal sparring on your key challenges in understanding medical device commercialization or regulatory framework, allowing you to concentrate on the special features and needs of your own innovation!

Topics of this session

  • Innovating in a regulatory industry
  • Commercialization of medical devices
  • Quality management according to ISO 13485
  • Medical device development (IEC 62304, ISO 14971, ISO ?)
  • 1-to-1 sparring

Trainers

Mikko Juuti
Mikko Juuti
Key Account Manager
mikko.juuti@labquality.com
Mikko Juuti is an experienced trainer and coach in medical device commercialization. He has 20+ years of experience in Labquality, Kasve, VTT, and the University of Eastern Finland in several positions supporting commercialization. He is also an investor in deep tech, chairperson of the board at Nostetta Ventures, and board member of several technology startups.
Terhi Heikkinen
Terhi Heikkinen
Quality & Regulatory Affairs Manager
terhi.heikkinen@labquality.com
Terhi is a medical device professional with over 20 years of experience in product development, quality, and regulatory affairs as well as quality management system development. She has held responsibilities for building or improving QMS and technical documentation to enable QMS certification or product registration. Terhi has an extensive experience in project design control, risk management, verification and validation activities, CE and 510(k) submissions, and ISO 13485, EU MDR, EU IVDR, and FDA quality system requirements and their implementation.

Target group

Research to business teams (R2Bs) and accelerators, startups, and individuals working in health tech innovations. 

After this session, you

  • You will learn the most common standards used in the health tech field and how to apply them in practice.
  • You will know the most common pitfalls in the commercialization of medical devices.
  • You can increase the skills to support the implementation of the regulatory strategy and gain new competencies in quality assurance and regulatory affairs.
  • You will ensure competitiveness and the common interests sought by action.
  • Personal sparring ensures your ability to innovate, learn continuously, collaborate, and develop.

Notice

The training is suitable for individuals starting the commercialization or preparation of a medical device, whether a physical device or software. It will be conducted in English, and training materials will be available after the training.

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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