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Event info
Date:04 May
Time:08:30 - 11:00
Venue:Medicon Valley Alliance, Copenhagen
Contact person
Mia Ritterband-Rosenbaum

Mia Ritterband-Rosenbaum

Event Manager & PA to CEO

+45 21 63 38 88

Optimal Regulatory and Design Development from Idea to Success of a Medical Device

To succeed in taking a medical device product from idea to the market, both the design and development flow, as well as the regulatory flow need to be considered. As the inventor or manufacturer of a medical device, a key success factor is to choose the right partners, that have the capacity to meet your needs, throughout the device life cycle.

Whether being a small start-up company or part of a larger corporation, it is common to outsource parts of, or even the entire design and development, or the manufacturing process. To successfully pass the Notified Body review and both achieve and maintain a CE-marking, you need to demonstrate control over any outsourced activities.

In this seminar we will look into how this can be reflected in your Technical Documentation and your Quality Management System, and important aspects to consider in stakeholder relations. We will also talk about designing safe and effective devices, and how to turn a design into a product that can be manufactured in volumes. To be able to ensure manufacturability in design, it is important to select the manufacturing partner and involve them in the project as early as possible.

In this seminar two MVA members, Key2Compliance and Innokas Medical, join forces to share more holistic insights about medical device development in a panel talk and warmly welcome you to join the discussion.

Date: Thursday, 4th of May, 2023
Time: 8:30 – 11:00 CET
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium



08:30 Networking, registration and light breakfast
09:00 Welcome
David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance
Jan Hellqvist, CEO, Key2Compliance
Matz Johansson, Sales Manager, Innokas Medical 

09:10 The crucial role of medical device risk management in designing safe and effective devices
Jenni Tuulos, Head of Design Studio, Innokas Medical

  • How to utilize and combine the vast experience and proven solutions throughout the life cycle of the product.
  • How to design a medical device that in addition to complying with the regulations can be manufactured and maintained efficiently.
09:25 Medical device productization, why thriving in the market calls for successful design transfer and NPI (new product introduction) processes?
Pasi Komulainen, Project Manager, Innokas Medical

  • To get your medical device into the market, you need to be able to turn your design into a product that can be manufactured in volumes. Why is this phase so important and what kind of expertise you need to have to succeed in it?
10:00 Stakeholder relations within the CE-marking process
Åse Ek, Senior Consultant and Trainer at Key2Compliance

  • How to ensure compliance to MDR/IVDR and ISO14971:2019 and demonstrate control over outsourced processes, both in the Technical Documentation and through your quality management system.
10:40 Panel discussion
Moderated by Jan Hellqvist, CEO, Key2Compliance
11:00 End of Good Morning Meeting



Jenni Tuulos, Head of Design Studio at Innokas Medical
Jenni Tuulos has a long experience of the Medtech industry from various roles. For the last ten years, she has worked for Innokas Medical and is currently heading the company’s Engineering operations. Jenni has an extensive knowledge of design and development projects of a vast range of medical devices and of what are the characteristics of a successful medical device design project.
Pasi Komulainen, Project Manager at Innokas Medical
Pasi Komulainen has a long experience of the technology industry from the ICT as well as manufacturing and medical device fields. Pasi has worked for Innokas Medical for five years and is currently managing Design and Design Transfer projects for medical device products. In addition to his hands-on experience of a wide range of medical device projects, Pasi is an experienced speaker having held a lecturer’s role at the Oulu University of Applied Science.
Åse Ek, Senior Consultant and Trainer at Key2Compliance
Åse has more than 20 years of experience in the Medical Device and Pharmaceutical industries. Åse has worked with product development, project management and quality and regulatory issues. In recent years, especially with QA / RA in post market surveillance and issues related to public procurement, marketing, and distribution.
Jan Hellqvist, CEO, Key2Compliance
Jan Hellqvist has been in life science for thirty years. He has been in leading positions in companies like AstraZeneca, Orifarm, Stryker, DAKO Agilent, TFS and others. He has been working both with Pharmaceuticals, Diagnostics, Medical Device and Services. Currently he is the CEO of Key2Compliance, a quickly growing and leading consultancy and training & education company.



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