Regulatory expertise. A clear stance. Personal responsibility.
Our team
Different areas of expertise, one point of contact. Anyone who contacts us doesn’t need to know who’s responsible – just what they need help with.
We understand the challenges that medical device manufacturers face in their day-to-day regulatory work – because we have been tackling them together for years.
Robin Stock
Consultant
Master’s Degree in Biomedical Management and
Marketing (M. Sc.)
Technical documentation, post-market surveillance, clinical evaluation/performance evaluation, risk management, software & AI, digitalisation
Frederike Brühschwein-Mandic
Senior Consultant
Graduate Engineer Applied Science (FH) in Medical Engineering
MDR certification/CE marking, technical documentation, regulatory affairs, international approvals, usability, software & AI, approval in the USA and Canada
Gerhard Willberger
Consultant
Business Administration
Technical documentation, quality management / ISO 13485 / MDSAP / 21 CFR 820, regulatory writing, marketing / communications
Andreas Esch-Brödner
QM Documentation Specialist and Assistant
Finance & Controlling, Seminarmanagement
Katharina Ellmayer
Consultant
Bachelor´s Degree in Healthcare Management (B. Sc.)
MDR certification/CE marking, technical documentation, quality management/ISO 13485/MDSAP/21CFR820, audits (internal, external), digitalisation
Robert Karl Ibler
Founder | Senior Consultant
Master´s Degree in Physical Engineering
MDR certification/CE marking, technical documentation, quality management/ISO 13485/MDSAP/21CFR820, audits (internal, external), risk management, finance & controlling, seminar management, digitalisation
Dr. Barbara Malitschek
Senior Consultant
Degree in Molecular Biology (Dr. rer. nat.)
MDR certification/CE marking, technical documentation, regulatory affairs, biological evaluation, international approvals, UDI registration, approval in the USA and Canada
Thomas Ceferino Kutschenreiter
Managing Director | Senior Consultant
Graduate Engineer Applied Science in Engineering Physics
Quality management / ISO 13485 / MDSAP / 21 CFR 820, audits (internal, external), risk management, statistics, process validation, UDI registration, marketing / communications, digitalisation
Julia Lorenz
Managing Director | Senior Consultant
Master´s Degree in Industrial Engineering
MDR certification/CE marking, technical documentation, quality management/ISO 13485/MDSAP/21CFR820, post-market surveillance, clinical evaluation/performance evaluation, regulatory affairs, international approvals, digitalisation
Alexander Popp
Senior Consultant
Master´s Degree in Mechanical Engineering (M. Sc.)
MDR certification/CE marking, technical documentation, quality management/ISO 13485/MDSAP/21CFR820, regulatory affairs, audits (internal, external), risk management, international approvals, process validation, approval in the USA and Canada
Andreas Schlichting
Consultant
Diploma in TQM and Computer Science
Graduate Engineer Applied Science in TQM and Computer Science
MDR certification/CE marking, technical documentation, quality management/ISO 13485/MDSAP/21CFR820, audits (internal, external), risk management, software & AI, seminar management, digitalisation
Franziska Tretter
Consultant
Bachelor`s Degree in Technical Writing/ Technical Communication (B. Eng.)
MDR certification/CE marking, technical documentation, quality management/ISO 13485/MDSAP/21CFR820, post-market surveillance, regulatory writing, seminar management, marketing/communication
Hans-Peter Wettl
Founder | Senior Consultant
Master´s Degree in Electrical Engineering (M. Sc.)
MDR certification/CE marking, technical documentation, quality management/ISO 13485/MDSAP/21CFR820, regulatory affairs, regulatory writing
Yves Eicke
Consultant
Graduate Engineer Applied Science in Mechanical Engineering
& Master´s Degree in Medical Engineering (M. Sc.)
MDR certification/CE marking, quality management/ISO 13485/MDSAP/21CFR820, regulatory affairs, risk management, statistics, process validation, digitalisation
Dr. Harald-Gerhard Geppert
Senior Consultant
Dr. rer. nat. (Graduate chemist), Chemistry / Biochemistry
MDR certification/CE marking, technical documentation, post-market surveillance, clinical evaluation/performance evaluation, regulatory affairs, risk management, IVD/IVDR certification, regulatory writing
No call center, no ticketing system. You don’t need to know who handles your topic — just describe your situation, and we’ll bring the right expertise together internally.
Free initial consultation