Regulatory guidance for medical devices (MDR)
Making your medical device, such as a health app, marketable requires extensive regulatory expertise. From the design of the intended purpose to the assignment of the device to a risk class based on relevant classification rules, to the preparation of the technical documentation, the comprehensive requirements of the Medical Device Regulation (MDR) must be considered. Software as a medical device in particular faces the challenge of often being directly assigned to the risk class IIa, which makes the involvement of a notified body (e.g. TÜV) mandatory in the conformity assessment procedure.
We will be happy to assist you in creating the necessary proof of conformity and provide you with comprehensive templates for this purpose, which we will adapt together with you to meet the individual needs of your company. The goal here is to apply our pragmatic consulting approach to bring you to a certifiable state with as little effort as possible. In addition, we are available to conduct internal audits and accompany you during your certification or surveillance audit.
Whether you are a manufacturer of a medical device or a digital health application (DiGA – Digitale Gesundheitsanwendung), or a development agency programming software as a medical device on behalf of a manufacturer, you will need at least a rudimentary quality management system, depending on the role you play in the context of the MDR. However, such a system should by no means “overwhelm” you, but rather advance your company. For this reason, we take a purely process-oriented approach and rely entirely on digital solutions to implement the demands of the authoritative standards and regulatory requirements as practicably as possible in close cooperation with you. For us the principle is “as much as necessary, as little as possible”.
We would be happy to support you in setting up and implementing your individual quality management system. Our focus is on systems according to ISO 9001 and ISO 13485 (for medical devices) standards. In addition, we are available to conduct internal audits and accompany you during your certification or surveillance audit.
Regulatory guidance for digital health applications (DiGA)
Digital medicine has arrived in the primary healthcare market. But the road there is not easy. From the basic establishment of the marketability of the DiGA (Digitale Gesundheitsanwendung) as a low risk-class medical device (I or IIa), to compliance with the specifications from the DiGAV for evidence-based proof of positive effects on care. The reimbursability of a DiGA is based on regulatory requirements that must be observed by the manufacturer. We support you on your way from the idea to reimbursement and navigate you safely through the “regulatory jungle”.
As a manufacturer-independent institute, we can also review your evaluation concept with regards to the necessary compliance with the requirements of the DiGAV and certify its suitability for the further application process. We are also available to advise you on the preparation and conduction of your consultation with the BfArM.