Our vision

To provide outstanding and unsurpassed services of clinical evaluation and regulatory affairs for our clients, and create a brand trusted by medical device manufactures, notified bodies and competent authorities.

Our mission

With the upcoming Regulation (EU) 2017/745 medical device manufacturers are targeted with higher expectations on their clinical data.

As a service provider focused on Clinical Evaluation, we aim to be world leader at finding efficient solutions for our clients and enable the medical device industry as well as regulatory authorities to ensure patients with access to safe and high-quality medical devices.

Who we are

We are a high quality international provider of outsourced services to the medical device industry, specialized around clinical evaluation and post-market clinical data management.

Meet our founders.

Why us

We are the only service provider highly focused and we pay great attention to the quality of services offered to our clients.

Our experience

We are a team of experienced and dedicated scientists, medical and regulatory affairs experts which work together as a cohesive force to compile state-of-the-art and regulatory compliant clinical evaluation reports. We have an excellent understanding of the regulatory requirements and regularly exchange with experts in the field.

Our diverse team of qualified authors and evaluators has a broad experience in various areas of the medical device industry and pharmaceuticals. Together we have been involved in more than 150 Clinical Evaluation Reports ranging from class I single use devices over active class IIa and IIb devices, to class III implants and combination products.

In addition to our clinical evaluation expertise we have worked in Regulatory Affairs including Risk Management, Quality Management and supported Clinical Investigations.

Class I
Class IIa
Class IIb
Class III

Our expertise

  • Orthopeadic implants
  • Single use devices
  • Radiology devices
  • Life-support systems
  • Substance based products
  • Drug delivery devices
  • & many more