Regulation follows innovation
4 November 2020
The laws, regulations and standards hang like a sword of Damocles over the heads of medtech companies, especially medtech start-ups. The topic of "overregulation" seems to have become a daily mantra. But do regulations really slow down innovation?
Navigating with the right mindset
Do regulations really slow down innovation? The answer is: regulation is not the problem. With the right mindset and the necessary skills and experience, you can use the Regulatory Framework to your advantage and put your projects on the road to success right from the start!
Navigation tools through the Medtech jungle
A certain basic understanding is required in order to use the corresponding rules and regulations for navigation. But let's be honest: this know-how falls far from falling into the category of "Rocket Science".
Ready for the paradigm shift?
So what is to be done? An optimal basis for the Regulatory Mindset can be laid when companies are ready for a paradigm shift. Our key messages are:
- Implement and live a risk-based development mindset
- Documentation: What is not documented has not been done
- The company itself is responsible for how simple or complicated the processes are defined and lived
Support by external specialists: benefit from konplan's expertise
If there are problems at one point or another, or if you lack the knowledge for a certain area, you can easily get support from outside. According to the motto "together you are less alone" we will tackle the task together. konplan is a valuable partner for your medtech company when it comes to navigating efficiently through the labyrinth of the medtech jungle according to the regulations and normative guidelines.
konplan systemhaus ag is at your side at any time. What qualifies us? An excellently developed network, constant exchange of experience with other specialists in the industry, experience with regulatory requirements - especially in the implementation of medtech projects - across all development steps up to market launch.
Do you also need support for your medtech company? Then please contact us - we look forward to working with you to bring innovative ideas to life!
Registration of medical devices