09:00 - 15:30
Fauna (meeting room in Forskningsparken)
Are you a MedTech Startup scratching your head on product development and all the regulatory stuff to consider early on? We’ve invited Yallow Life Science to learn you how to stay creative and agile while still effectively and safely go from idea to market launch (and beyond) with a medical device.
Most medtech startups have great technical expertise and, naturally, that is their focus. However, there are a number of considerations surrounding product development (already at early stage) that are, too often, overlooked and pose a threat to the company’s sustainability and efficiency in bringing their product to the market.
For example, a Quality Management System setup early on is a great foundation for a company, providing a good base to streamline the activity in your company and build evidence to sustain your medical claim and regulatory work down the line. Yet, few companies consider this upfront.
The colleagues from Yallow will take us through this and other aspects to open your minds to the combined journey of Product Design and Design Control and how to navigate it successfully.
The indicative agenda is as follows:
Part 1 – 9:00-10:20
- Design Thinking
- Design Control
- Design X Control
- Medical Product Development
- What is a Medical Device and what does it means?
- Get a good start – early phase development activities
- User centric
- Regulatory Strategy
- Intended use
- The Product Development Process
Part 2 – 10:40–12:00
- Design Control Process using Case, Step-by-step
- Summary, Evaluation and Take Aways
- Wins by combining design driven approach on design control
Part 3 – 13:00-15:30
- One2one discussions with Yallow’s experts (20-30 minutes per company)
If you’re interested in a one2one discussion with Yallow’s experts please indicate that when registering.
Covid19 disclaimer: The plan is to host a physical meeting for this training in Forskningsparken, with a limit of 20 attendees on the room but due to the Covid 19 situation, this may change and we may be required to do the event fully online. A link to the web-meeting will be provided to registered attendees prior to the seminar.