ISO 13485 Certified CROs

Global CDMO with 30+ years delivering development and manufacturing for biologics, cell therapies, viral vectors, and mRNA across US, European, and Asian facilities.

Global CRO built exclusively for MedTech, integrating regulatory strategy, clinical development, and market access reimbursement for device and IVD programs from the Netherlands since 1988.

Munich-based specialty CRO focused on medical device and in vitro diagnostic clinical studies, providing regulatory consulting, study monitoring, and clinical evaluation reports across Europe.

European specialist CRO and regulatory consultancy for IVD and medical device companies, with IVDR and MDR expertise across offices in Lisbon, London, Barcelona, and Madrid.

Quality control reference material provider and testing laboratory serving pharmaceutical, medical device, and clinical diagnostics industries with microbiology standards.

Leading medical device CRO providing biocompatibility testing, sterilization validation, regulatory consulting, and clinical services for medical device and combination product development.

Premier provider of sterilization validation, microbiology, and biocompatibility testing services for medical devices. Part of Sotera Health, serving the global healthcare industry.

Tokyo-based CRO and CDMO providing contract manufacturing of injectable formulations, lyophilized products, and sterile fills for Japanese and international pharmaceutical clients.

MedTech CRO formed by the 2020 merger of Regulatory and Quality Solutions and Maetrics, delivering 40+ years of medical device regulatory, clinical, laboratory, and reimbursement expertise.

Clinical-stage diagnostics and genomic testing company providing companion diagnostic development and biomarker-driven clinical trial services.

Innovation CRO purpose-built for medical device and IVD development, delivering integrated regulatory, clinical, and laboratory services across cardiovascular, neurological, and ophthalmic indications.

UK-based specialist CRO for ophthalmic and contact lens clinical trials, providing study design, clinical monitoring, and regulatory support for eye care medical devices and pharmaceutical products.