The Regulatory Journey – Product innovation training for startups

Regulations are an important part of the innovation process and product development.

Are you part of a Med-tech or health-tech start-up developing medical equipment for diagnostic purposes, treatment, or disease prevention? Do you have sufficient knowledge about the regulatory laws and regulations applying to your product?

This unique training will provide you with baseline knowledge on regulatory compliance and give you access to workshops and local experts. And it’s all free of charge.

Knowledge about the regulations of your solution is important when:

• Deciding your intended purpose
• Every iteration of your solution (hardware or software)
• Choosing suppliers
• In clinical investigation
• And many more…

The regulatory journey is for companies who are in their developing process. It is important to have the regulations in mind from the early product development stage.

The training aims to give you the necessary knowledge, tools, and feedback for regulatory compliance.

The program will provide detailed insight into the regulatory laws and regulations. Knowledge that is essential as part of the innovation process to define the intended purpose and develop your product in compliance with the regulations.

The focus will be on medical device regulation (MDR), equipment for in vitro diagnostics (IVDR), and medical software.

What do you get out of participating?

The program will support to ensure that the products and services you develop will fulfill the criteria for legislation, special requirements, and standards for obtaining CE marking.

The activities will e.g., help you to find the right consulting services for your need and when to make use of test facilities during the product development – to ensure certification of your product.

At the end of the program you will present the regulatory strategy that fits your product and your company.

Programme (activities)

1. Intro-workshop

• When: On-demand
• Where: Online.
• Topic: Introduction to the programme:
  • Access to Entries – a digital learning tool
  • Access to Webinars – online training series that will teach you the basics.
  • Sparring with mentors on experience and training needs.

2. Workshop on the AI Act

Here we focus on the AI Act – the rather new legal framework that address the risks of AI in your solution.

• Expert: Brian Hedegaard, Probatus.
• When: May 29th 2024
• Where: The Life Science House

3. Workshop on Clinical Investigation

It can be complicated to collect clinical data in compliance with the regulations. In this workshop we focus on how to collect proper data and the right data for getting your product to market

• Expert: Key2Compliance
• When: August 29th 2024
• Where: Copenhagen.

4. Q&A – Your opportunity to get insight knowledge

Here we focus on your questions. We assume you have done your preparations, and this is a great opportunity to ask the experts the questions you have left

• Experts: Lean Entries, Key2Compliance, Probatus
• When: TBA
• Where: Online.

5. Workshop regulatory strategy

• Experts: TBA
• When: Fall 2024
• Where: Copenhagen

6. Workshop on Notified Bodies

Notified Bodies perform assessment of your company and product before it is placed on the market. In this workshop we engage in a dialogue with the notified bodies on how they work.

• Expert: TBA
• When: Fall 2024
• Where: Online

7. Workshop regulatory strategy

• Experts: TBA
• When: november 26th 2024
• Where: Copenhagen

The activity is provided as part of the Danish Life Science Cluster’s EU project, Innovationskraft: Life Science and Welfare Technology, and is calculated as state aid under the de minimis regulation for the participating companies. The state aid is calculated to: 6,000 DKK

If you are from a company, participation requires a signature on a de minimis declaration, partner declaration, and SME declaration according to the state aid rules in the de minimis regulation.

This event is co-funded by the European Union and the Danish Business Authority.