Closed Loop Medicine Ltd., a leading TechBio company developing drug plus digital combination products that enable personalized dose optimization, is pleased to announce it has successfully achieved ISO 13485:2016 certification for its digital therapeutic platform.
The ISO 13485:2016 accreditation is a milestone that enables continual development of Closed Loop Medicine’s Quality Management System (QMS), supporting ongoing advancement of the Company’s digital medical device and delivery of all applicable compliance requirements across its product portfolio.
Closed Loop Medicine’s proprietary technology platform facilitates personalized drug dosing optimization, through integration of drugs and software with patient-led digital experiences and closed loop models of care. This approach has the potential to provide bespoke universal healthcare access and improve outcomes for patients with chronic diseases.
Dr. Hakim Yadi OBE, CEO & Co-Founder of Closed Loop Medicine, said: Our mission is to improve drug effectiveness and patient outcomes through development of a safe, protectable and scalable product solution that combines dose-optimized drug therapy with digital care. Achieving this QMS standard is hugely important to us and the progression of our portfolio of drug plus software combination products. We are commited to following international standards and maintaining compliance with regulatory requirements to ensure the safety and quality of our medical devices, and to deliver these to patients sooner.”