QUALITY AND REGULATORY COMPLIANCE IN MEDTECH & BIOTECH
We help to bring your innovative medical solution to the market
Quality and Regulatory Compliance in MedTech & BioTechWe help to bring your innovative medical solution to the market
What we do
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.
Signifix is a consulting company with passionate and experienced consultants in the field of medical devices, cell therapies, human tissues, vaccines and other biological medicines. We are proud to have been successfully serving our (inter)national customer base for more than 15 years.
WHO we are
Meet the team
A team you can trust
Seasoned and highly skilled professionals with an established industrial background and proven track record of successful & timely product development and approval processes, combined with effective implementation of certified quality systems.
News & Insight
Put the delay in MDR to good use. Get your Technical Documentation MDR ready with Signifix’ MDR Quick Scan. We can help you in 7 clear steps to achieve compliant documentation....
PRRC already identified and trained within your organisation?No in-house resources or expertise to check conformance of devices prior to their release as required per MDR?Looking...
Why use Signifix?
Signifix is a boutique consulting company and focussed on innovative biomedical, biotechnology & human tissue and medical product technologies. The road to approval is not simple such as advanced therapy medicinal products, medical devices, animal tissue devices and combination/ borderline medical solutions. Our range of consultancy services covers quality & regulatory strategies, design and implementation of quality systems, managing regulatory approvals (including 510(k), PMA, IDE, IND, BLA and CE mark). Support quality system certification processes in all phases of product development, auditing, training/coaching and problem solving.
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