Signifix consulting company in the field of medical devices, cell therapies, human tissues

QUALITY AND REGULATORY COMPLIANCE IN MEDTECH & BIOTECH

We help to bring your innovative medical solution to the market

Quality and Regulatory Compliance in MedTech & BioTech

We help to bring your innovative medical solution to the market

What we do

Services

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. Add text here

Human Tissue

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

About us

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

Eliane Schutte CEO Signifix

Eliane

CEO / Owner

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.

Jeroen Pieper Signifix

Jeroen

Principal RA consultant

RICHARD VAN DER LINDEN, PHD, RAC Signifix

Richard

Principal QA/ RA consultant

Sabine-Snaar Signifix

Sabine

Senior QA/RA Consultant

Paloma Passamani

Paloma

QA/RA Consultant

Jiva De Vetter, Junior Quality Assurance Consultant

Jiva

Junior QA/RA Consultant

Corina

Corina

QA/ RA assistant and office manager

Stay updated

News & Insight

 Unique skills

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

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

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Signifix