Cirle is a premier medical technology development company with a world-class experience team with deep industry, R&D, medical and ophthalmic expertise.
Cirle leverages an exceptional leadership and established R&D infrastructure.
Cirle has built internal capabilities to be a turn-key external technology and development partner. Our capital-efficient model focuses on value creation via rapid development and leveraging of commercial partnerships to bring products to market.
We are ISO compliant for medical device hardware and software development (60601-1,-2, 62304,13485,14971 compliant)
Cirle has extensive regulatory and quality assurance capabilities including:
U.S. (class I, II, III) and ex-U.S. expertise (CE Mark)
Hardware and Software (IEC 62304, FDA requirements) expertise
Internal expertise supplemented by world-class external experts
External partnerships for developing and submitting dossiers, as needed