Deep Dive Regulatory Affairs

Together with you, we outline the processes for approving a medical device in accordance with the EU Medical Device Regulation (MDR). This includes the classification of the own medical device, clarification of the related standards and processes, calculation of costs and time for the implementation of a QM system according to ISO 13485 as well as a roadmap for the implementation.

Key questions answered

Digital health solutions manufacturer & investors

In-depth knowledge of regulatory affairs, medical device regulation, medical device classification, CE marking, quality management, risk management, general ISO 13485 and related aspects.

Can be ordered directly together with Readiness Check if the need is already identified at that time or as a following step based on the result of the Readiness Check.

Can be commissioned not only as an add-on, but also as a stand-alone module with the appropriate level of knowledge.

The module creates further clarity or reduces uncertainty specifically in the chosen focus area by better understanding processes, requirements and stumbling blocks, better estimating efforts and risks, making more informed decisions and better planning/clearly defining next steps.

In particular, an approximate picture should emerge of the processes for the approval of a medical device according to MDR, classification of one’s own medical device in particular SW and Rule 11 MDR, related standards and processes (release management, usability, standard-compliant SW development and technical documentation, safety & security), costs and time for the introduction of a QM system according to 13485 and the necessary steps for this with reference to partner companies for implementation.

We act as a one-stop store for market access and reimbursement for digital health solutions. We provide knowledge transfer and consulting services specifically tailored to digital health solutions, especially in the areas of DiGA, DiPA and selective contracting.

Digital health solutions manufacturer & investors

In-depth knowledge of regulatory affairs, medical device regulation, medical device classification, CE marking, quality management, risk management, general ISO 13485 and related aspects.

Can be ordered directly together with Readiness Check if the need is already identified at that time or as a following step based on the result of the Readiness Check.

Can be commissioned not only as an add-on, but also as a stand-alone module with the appropriate level of knowledge.

The module creates further clarity or reduces uncertainty specifically in the chosen focus area by better understanding processes, requirements and stumbling blocks, better estimating efforts and risks, making more informed decisions and better planning/clearly defining next steps.

In particular, an approximate picture should emerge of the processes for the approval of a medical device according to MDR, classification of one’s own medical device in particular SW and Rule 11 MDR, related standards and processes (release management, usability, standard-compliant SW development and technical documentation, safety & security), costs and time for the introduction of a QM system according to 13485 and the necessary steps for this with reference to partner companies for implementation.

We act as a one-stop store for market access and reimbursement for digital health solutions. We provide knowledge transfer and consulting services specifically tailored to digital health solutions, especially in the areas of DiGA, DiPA and selective contracting.

Your message to us

Do you have questions about your digital health solution, possible reimbursement channels or the German healthcare market? The dmac is at your side with all its expertise – our competent team will be happy to support you.

Contact us with your request via the form and we will get back to you as soon as possible!

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