Unlock your full market potential with our pragmatic CE, ISO 13485 and ISO 27001 support
Apply proven, pragmatic strategies to build a compliant Quality Management System, audit-ready documentation, and accelerate your path to market. Delivered with efficiency and supported by deep quality and regulatory expertise.
Unlock market access
Get certified faster with end-to-end ISO 27001, ISO 13485 and CE support, from initial application to ongoing compliance
Smooth market access
Reduce delays and simplify approvals with our proven process and hands-on support.
Building Relationships
Trust is essential for every PRRC relationship, it’s what enables us to protect your organisation and ensure full regulatory compliance.
Our Story
We started with one mission: ensure that safe and effective medical devices and in-vitro diagnostic devices will reach the market to make an impact on the world. Our excellence services are based on real-world experience, avoiding delays in market access.
Supporting (start-up) medical device manufacturers, distributors, importers and authorised representatives
Our Services
Regulatory Compliance Services
Get better results with less effort by using systems that save time and boost consistency.
Quality Management System
Development, implementation, and optimization of your Quality Management System.
Training Programs Professionals
We offer a diverse range of hands-on training courses, e.g. MDR/ ISO 13485/ ISO 14971.
Auditing Services f0r Experts
Audit services for different types of audits, e.g. Internal, Supplier and Notified Body.
Strategic Advice for MDs & IVDs
Strategic advice to navigate the complex regulatory landscape for market access.
Driven by Results
Our service is your smootest way to CE
15+
YEARs of experience
75+
happy customers
10+
Experience with different notified bodies
150+
Professionals trained
What Our Customers Are Saying
Ward van Buul, Jointsphere B.V.
Lizette demonstrated exceptional dedication, guiding us smoothly toward a successful Stage 1 audit. Her professionalism, energy, and clear expertise made the entire process a pleasure. With the first steps toward Stage 2 already underway, I’m fully confident that we’ll achieve another great result.
Tom Doodkorte, Enraf-Nonius BV
“Taken through the landscape (and all obligations) of the MDR in a very structured way. It was a pragmatic and hands-on training. Thank you so much”
REGINA SHih, COOPERSURGICAL INC
I would recommend Lizette to any medical device company who needs support for MDR compliance. She has always been on top of all tasks and was able to identify many areas for improvement by her incredible audit skills and insight for the quality management system. Her knowledge in the EU MDR regulation and compliance requirements is solid.
BILIHOME B.V.
Just recently Lizette has guided us through the 510(k) approach for our solution. Not only confirming our regulatory strategy, she even gave us concrete step-by-step approach towards an FDA approval. This helps us to plan time and money. Bilihome can recommend Lizette de Groot for a first and thorough assessment of a regulatory pathway to the US.
