Signifix
Services
Signifix is a boutique consultancy company focused on global access for innovative medical devices, human tissue allografts and cell therapies
![MedicalDevices](https://www.signifix.nl/wp-content/uploads/2020/05/MedicalDevices.png)
Medical Devices
Market approval processes including EU MDR – CE certifications – US FDA clinical trial and US device approvals. Implementation of ISO 13485 quality management systems.
![HumanTissues](https://www.signifix.nl/wp-content/uploads/2020/05/HumanTissues.png)
Human Tissues
Tissue establishment licensing services including responsible person activities. Regulatory and quality processes towards market approvals, market access in both EU and US.
![CellTherapy](https://www.signifix.nl/wp-content/uploads/2020/05/CellTherapy.png)
Cell Therapy and Biologics
Regulatory and quality processes towards clinical trial readiness, marketing authorization (EMA), biological license application (FDA), GDP activities.
Get in touch
Contact us
Contact
Jeroen Pieper
+31 (0)6 1146 1426
Richard van der Linden
+31 (0)6 2862 2870
Office
+31 (0)30 229 72 10
Email: info@signifix.com
Signifix BV
Professor Bronkhorstlaan 10
Building 86
3723 MB Bilthoven
The Netherlands