Our Services

With more than ten years experience in Quality Assurance, Regulatory Affairs, and Clinical Affairs in the Medtech Industry, we can support you in the following areas:

Regulatory Compliance

Ensuring your medical devices meet all required regulations and standards globally, including FDA, MDR, and ISO certifications.

Clinical Research

Comprehensive support in setting up and running of clinical studies for gaining access to the market, or to collect Post-Market Clinical Follow-up data.

Quality Management Systems

Implementation and maintenance of QMS compliant with ISO 13485 and other relevant standards, tailored to your organization's needs.