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.
Be it a small start-up company or a 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 Medicon Valley Alliance Good Morning 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. In order 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
The event is free of charge for all MVA members and organisations considering an MVA membership, please read more here: About MVA Good Morning Meetings and event policy
As a full-service partner, Key2Compliance is assisting companies in the life science area with everything from risk management and compliance, to training and guidance on how to meet the regulatory requirements. More about Key2Compliance