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Medical consulting born of experience

Standards, rules, regulations: The medical sector certainly has plenty of challenges in store for new medical products. As your certified partner of choice, we have the know-how to rise to the occasion. We accompany you from the beginning to the approval with this motto in mind: What we advise, we can also provide.

Our services

Regulatory consulting in connection with MDR, IVDR and FDA

Support for ISO 1497:2019 – compliant risk management

Consulting on Quality Management according to ISO 13485:2016

Consulting to cover cyber security, usability engineering and software development

Post-market surveillance

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Success Story

Managing and documenting development processes in real time

Rigorous standards in medical engineering make continuous monitoring on applications throughout their lifecycle a must-have. Application lifecycle management (ALM) tools serve to manage documents and development processes to enable seamless traceability for the system development effort. Let us help you digitalize your workflows and come up with a solution tailored to fit your needs. And if you want to manage QM documents with Polarion, that will not be a problem.

Team works on a project


Risk management – typical pitfalls in the course day-to-day development work

Ultrasound devices, surgical robots, apps for monitoring blood glucose levels – medical products are all beneficial to humans regardless of their complexity. But practically they also entail risks for patients, users, or third parties. Minimizing risks while maximizing benefits is a matter of striking an acceptable balance. So how can development help achieve the best possible risk-benefit ratio?

Advice rooted in real-world experience A safe, secure journey to a medical product

Digitalization is the driving force behind innovations in medical technology. We not only develop components and full-fledged solutions; we can also advise you on new business models and technologies that will gear your products up to get them connected. Rest assured, we will be there for you throughout the entire development process.

Unsolved challenges? We look forward to your inquiry.

TK-Kontakt: Dr. Moritz Killat

Healthcare – Medical Consulting

Dr. Moritz Killat