Mediacc GmbH

MEDIACC is the owner-managed, independent scientific institute for medical and academic consulting and services. With more than 35 years of scientific and regulatory expertise, we specialise in helping medical device manufacturers achieve evidence-based reimbursement for their innovations through tailored study concepts.

Our interdisciplinary team combines medical, regulatory and scientific expertise, proven in numerous studies with medical devices, in particular DiGA seeking provisional or permanent listing. In addition, our operational team at the digital study centre (DTC-MED®) can take full charge of the randomised controlled trials (RCTs) required by the BfArM nationwide from a single source, from initial information to participant support to achieve high retention rates.

Digital and hybrid study designs: we are pioneers in conducting fully digital nationwide clinical studies and offer flexible solutions from traditional to fully digital. DiGA expertise: as recognised experts in digital health applications, we have successfully supported numerous listed DiGA in generating evidence. Regulatory consulting: from strategy development and BfArM consultations to price negotiations, we guide you safely through all regulations. Analysis and clinical outcome assessment: from initial data to convincing results for your medical device

• More than 500 successfully conducted clinical studies • More than 4,000 patients in our digital studies • Information security established in accordance with ISO/IEC 27001:2017 • BVMA membership and implementation of current regulations and GCP • Participation and delegation in the revision of ISO 14155 in the DIN Standards Committee for Healthcare Technology

What makes us special: we complement your expertise with proven experience and a focus on evidence generation for software as a medical device.