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ISO 9001:2015 Certification
We're ISO 9001 Certified! We’re proud to announce that Signifix obtained ISO 9001:2015 certification scoped around regulatory and quality consultancy services focused on innovative medical devices, human tissue transplants, and cell therapies. Jeroen Pieper, Principal...
Sabine Snaar earned her credential as RAC certified professional
We are happy and proud to announce that Sabine Snaar has passed her exam and successfully obtained the officially RAC Drugs certification as an individual with the Regulatory Affairs Professionals Society! This makes that we are now with 4 RAC certified consultants...
COVID-19 is an acute problem worldwide. Now is the time to join forces as much as possible.
Signifix B.V. is a consulting company with driven and experienced consultants in the field of medical devices (CE Marking), vaccines and other biologic medicines.We offer quality and regulatory support, such as:- Regulatory strategy- Product files- Interaction with...
Products covered under the MDR? Looking for MDR relief?
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. Contact us for a free 1 hour intake to get started, info@signifix.com. Class I medical...
PRRC already identified and trained within your organisation?
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 for MDR relief on this topic? What to do and where to start? Signifix offers PRRC...