17/10/2025 Hospitals, Clinics
Bringing a medical device to market demands more than just clinical execution — it requires a partner who truly understands the science, regulations, and realities of the medical device industry.
We are a full-service, medical device–focused CRO dedicated to supporting manufacturers through every phase — from clinical strategy and regulatory submissions to post-market follow-up.
Why Leading Device Companies Choose Us:
Deep expertise across Class I to III devices
Proven success with EU MDR, FDA, and global regulatory requirements
Efficient patient recruitment and site management tailored for device studies
Integrated data management and quality systems ensuring audit-ready results
Flexible, transparent collaboration built around your timelines and goals
Whether you’re a startup preparing your first clinical investigation or an established manufacturer expanding globally - we bring the experience, infrastructure, and commitment to make your trial a success the first time.
Bringing a medical device to market demands more than just clinical execution — it requires a partner who truly understands the science, regulations, ...
CE Marking for Medical Devices in Germany: Your Gateway to the EU Market The CE Mark is essential for medical device manufacturers aiming to sell thei...
Sustainable biomaterials for medical devices are revolutionizing the healthcare industry by offering eco-friendly, biocompatible alternatives to tradi...
Looking to set up a medical device manufacturing facility in the USA? Operon Strategist offers expert consulting services for end-to-end facility setu...
More Details