Specialty MedTech and combination product CRO, offering end-to-end development services and digital solutions to MedTech companies.
What we do:
We provide integrated end-to-end support across regulatory, clinical and quality with deep expertise in EU MDR, IVDR, FDA regulations, and global compliance. We help accelerate market access, control development costs, mitigate regulatory risks, and provide tailored expert guidance at every stage
Therapeutic areas of focus:
Cardiovascular – Dermaesthetics – Ophthalmology – Oncology – Orthopaedics
What we offer:
Regulatory strategy & submissions (MDR, IVDR, FDA 510(k), PMA, etc.)
Clinical trial design & management (ISO 14155, ICH GCP)
Quality system support (ISO 13485, 21 CFR Part 820)
Post-market surveillance & real-world data
Digital solutions: 1data, 1Survey+
