Professional services for Medical Device and IVD Regulatory Compliance

We offer consultant expertise focusing exclusively on Regulatory Affairs and Quality Assurance for Medical Devices.


With our personal and professional services, we customized strategic solutions for Regulatory Compliance. 

Main services

Our focus is to guide and support you in every aspect of Regulatory Affairs and Quality Assurance. Our consultant team of experts have extensive experience and knowledge within EU and US Medical Device and IVD Regulations. We partner up with our clients to create value and strategic advantages.

Regulatory Affairs

The Medical device regulatory landscape is hard to navigate as it demands a compliance process that follows the ever-changing framework. As experts, we support and guide you with the strategies and execution plans needed. Our focus is to find the most efficient and optimal solution for you.


Quality Assurance

Always stay one step ahead with a smart Quality Management System in place. We support you in every step – from GAP-analysis, internal audits to setting up and configuring the system. If needed, we can be your Quality Assurance Expert and take care of all QMS related activities for you.


Other services available

We offer a wide range of consultancy services covering the field of compliance for medical devices and IVD.

Contact us for more information


Person responsible for regulatory compliance (PRRC)

As EU medical device regulatory affair and quality assurance experts, we fulfill the competence requirements on PRRC in MDR and IVDR and can act as PRRC on behalf of small companies.

EU authorized representative

All medical device manufacturer located outside EU must have an EU Authorized Representative based within the EU. We guide you and can act as your EU Authorized Representative.

UK Responsible Person

All medical device manufacturer located outside UK that wants to sell their medical devices in the UK must, as a result of Brexit, have an UK Responsible Person. With our office in the UK we are able to act as your UK Responsible Person and guide you through the UK specific requirements.

Clinical investigation and Performance Evaluations

We have extensive experience with all types of clinical investigations of medical devices and Performance Evaluations of IVD. We can support you regardless of product, clinical developmental stage or type of design.

Medical Writing – Clinical Evaluation and Performance Evaluation

Our medical writing team are experts in performing CER / PER for medical devices and IVD. We can help you find the best way to prepare your CER / PER in compliance with applicable regulations and guidelines.


Within the Biocompatibility and Toxicology field, we support you in selecting the right biomaterial, planning and executing a Biological Evaluation and setting up Toxicology and Risk assessment strategies.

Our ecosystem for full-service medical device compliance

Together with Devicia, LimulusBio, Lea Reg and Kickfile, we support all your needs, everywhere, every time. Irrespective if it relates to strategy, Quality Assurance, Regulatory Affairs, Clinical Affairs, Biocompatibility, UK representation or EU Authorized Representative. We got you.


Devicia is a full-service partner offering regulatory and clinical expertise for medical devices. As members of the technical committees’ writing medical device standards, Devicia are always up-to-date with the latest news and regulations and take part in the process of decision making.


Limulus Bio

Limulus Bio is your partner in the field of Biocompatibility & Toxicology for medical devices and support you with Risk Assessment Strategies, material guidance and Biological Evaluations.



Kickfile aims to simplify the process of compliance by providing a cloud-based document system supporting clinical evaluations and investigations.