Signifix is a boutique consultancy company focused on global access for innovative medical devices, human tissue allografts and cell therapies
Market approval processes including EU MDR – CE certifications – US FDA clinical trial and US device approvals. Implementation of ISO 13485 quality management systems.
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
+31 (0)6 1146 1426
Richard van der Linden
+31 (0)6 2862 2870
+31 (0)30 229 72 10
Professor Bronkhorstlaan 10
3723 MB Bilthoven