Signifix is a boutique consultancy company focused on global access for innovative medical devices, human tissue allografts and cell therapies

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.

Human Tissues

Tissue establishment licensing services including responsible person activities. Regulatory and quality processes towards market approvals, market access in both EU and US.

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

Jeroen Pieper
+31 (0)6 1146 1426

Richard van der Linden
+31 (0)6 2862 2870

+31 (0)30 229 72 10


Signifix BV
Professor Bronkhorstlaan 10
Building 86
3723 MB Bilthoven
The Netherlands

Linked In Icon