Regulatory pathways such as for borderline products, combination products, IVDs or mobile apps as medical devices are quite challenging.

Our passionate team of biologists, chemists, physicians, clinicians, engineers, IT and software experts are able to evaluate projects from many different angles.

We provide synergies to help you find the key to the right strategy.


Our Team Members

Management

Dr. Hans Zanker

Dr. Hans Zanker

Managing Director


Active Medical Devices / Software as a Medical Device

Oliver Hilgers

Oliver Hilgers

Regulatory Affairs Expert
Authorized Officer
Medical Software / Apps
Active Medical Devices

Ittipan Kanluan

Ittipan Kanluan

Regulatory Affairs Expert
Medical Software / Apps
Active Medical Devices

Sohaib Ahsan

Sohaib Ahsan

Regulatory Affairs Expert
Medical Software / Apps
Active Medical Devices


Medical Devices / Combination Products / Borderline Products

Marcel Woellbrink

Marcel Woellbrink

Regulatory Affairs Expert
Medical Devices
Combination Products

Felix Metzner

Felix Metzner

Regulatory Affairs Expert
Medical Devices
Combination Products


In Vitro Diagnostics / Companion Diagnostics (CDx)

Tobias Bartl

Tobias Bartl

Regulatory Affairs Expert
In Vitro Diagnostics / CDx
Medical Devices

Linda Mayer

Dr. Linda Mayer

Regulatory Affairs Expert
In Vitro Diagnostics / CDx


Supported by Dr. Regenold team members:

  • Clinical team with 7 CER/PER experts / Represented by Christiane Chene
  • Legal / Represented by Luise Teml
  • Administration / Represented by Janina Karg
  • Accounting / Represented by Elena Ramos Delgado
  • Human resources / Represented by Christine von der Brelie