eco-system of medical device expertise

Choosing the right consultancy company is a key decision that often runs over several years. Our group of partner companies are founded on the belief that in order to provide the best support possible to our clients, we need to draw resources and expertise from highly specialized groups of employees. Together we offer unique expertise regarding Strategy, Quality Assurance, Regulatory Affairs, Clinical Affairs and Biocompatibility from a group of partner companies, working as one.

Clarvin - Regulatory Affairs & Quality Assurance exclusivity

Clarvin offers expertise and guidance within Regulatory Affairs and Quality Assurance exclusively for medical devices and In-Vitro Diagnostic medical devices. Our focus is to make your regulatory process as predictable and reliable as possible.

– Strategic Guidance in Regulatory Affairs
– Specialists in Quality Assurance
– EU Authorized Representative

Kickfile – MedTech compliance made easy

Kickfile offers cloud-based access to document systems supporting compliance.

With Kickfile, you get access to the systems you need for putting a medical device on the market – in a compliant and predictable way.

– Audited & up to date information
– Flexible plans & solutions
Cloud-based document systems

Limulus Bio – Global Biocompatibility Experts

Limulus Bio offers support within Biological evaluations & Toxicology consultancy and training – with a global perspective.

To meet the strict requirements in a compliant manner, we support you with comprehensive risk assessment strategies and biological evaluations

Consultancy, training and conferences
– Global perspective
– Customized services

Lea Reg – Your global and local partner

As your local partner Lea Reg support medical device and IVD companies to get global market access. With offices in the EU, UK, and US, we acts as your designated local representative or agent, and assist medical device companies to meet the regulatory requirements.

– EU Authorized Representative
– UK Responsible Person
– EU Importer / Exporter
– US Agent