The laws, regulations, norms, and standards hang like the sword of Damocles over medtech companies, especially medtech startups. The topic of “overregulation” seems to become a daily mantra. Does regulation really slow down innovation? The answer is: No, regulation is not the problem. With the right mindset plus the required skills and experience, you can make the regulatory system work for you and place your projects on the road to success right from the start!

A means of navigation through the medtech jungle

The conversion of applicable regulations and guidelines into useful navigational tools requires a specific fundamental understanding. But let’s be honest: this fundamental know-how is not “rocket science”.

Are you ready for the paradigm shift?

What exactly needs to be done? The optimal foundation for the regulatory mindset can be laid when the companies are ready for a paradigm shift. Our key messages are:

• Implement and follow a risk-based method of thinking for development
• Documentation: What is not documented was not done
• The company itself is responsible for the level of simplicity or complexity of its defined processes and how to comply.

Support from external specialists: benefit from konplan’s expertise

If you run into problems or lack the required knowledge for a certain topic, you can easily get external support. According to the motto “together we are less alone”, we will handle it as a team. konplan is a valuable partner for your medtech company when it comes to efficiently navigating through the labyrinth of the medtech jungle created by standards and regulatory requirements.

konplan systemhaus ag is always standing beside you. What qualifies us? An excellently developed network, a continuous exchange of experience with other industry specialists, extensive knowledge of regulatory requirements – especially in the implementation of medtech projects – across all stages of development up to market launch.

Do you need support for your medtech company, also? Then get in touch – we look forward to working together and bringing innovative ideas on the path to success!

Developing together! We put your ideas into practice and accompany your projects until they are ready for the market. Get in touch with our experts now.