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.

Program

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 MedicalTo 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