Regulation and security
We support you with all regulatory hurdles
Navigating the regulatory jungle of medical devices and data security is difficult. Moreover, such a challenge can quickly drive up the cost of developing a medical app or digital health app. We guide you through this jungle quickly and pragmatically.
What do we offer?
We act as your guide, offer you the practical support you need or take on responsibility for the following topics:
- Defining a pragmatic regulatory strategy (medical device, data security) for your solution
- Deriving a concrete and efficient regulatory roadmap
- Considering the requirements of relevant standards and specifications, for example:
- Medical devices: ISO 13485, IEC 62304/82304-1, ISO 14971, ISO 62366-1 and so on
- Data protection/security: GDPR, ISO 27001, IEC 81001-5-1, BSI specifications, such as TR-03161, and so on
- Medical studies: ISO 14155, German Ethics Commission (Ethik-Kommission), German clinical study guidelines (Studienleitlinien) and so on
- Specifications of the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), for instance via the DiGAV guidelines and so on
- Helping you with relevant processes – for example, customer support or post-market surveillance (PMS)
- Helping you with CE certification for your medical device according to its medical device class
Your benefits
Navigate the jungle of regulations with ease and take on as much responsibility as you can – we will help you with the rest.
Our solutions at a glance
Build your Health App with our software-based solutions - more efficient, regulatory compliant and affordable. Help your policyholders faster by accelerating your time to market.
Do you have any questions?
Would you like to find out more about Personal Health, do you have questions about our services or would you like to find out how we can specifically support you? Get in touch with us!