Klinik AI is regulated as a medical device, underscoring our commitment to rigorous development and deployment processes. We prioritise patient safety, effectiveness, and data security.

Our Compliance Framework:

• MDR Class IIa Transition: We are actively transitioning towards Medical Device Regulation (MDR) Class IIa certification from having it being registered as a Class I device, with a target completion well before the end-of-2028 deadline.
• ISO 13485 (Quality Management): Our quality management system (QMS) is built on ISO 13485, ensuring consistent quality and safety throughout the product lifecycle.
• ISO 14971 (Risk Management): We integrate systematic risk identification, analysis, evaluation, and control into every stage of development, aligned with ISO 14971.
• IEC 62366-1 (Usability Engineering): We follow usability engineering principles to design a user-friendly interface that minimizes errors for both patients and clinicians.
• Clinical Evaluation: A robust clinical evaluation process verifies the safety and performance of Klinik AI for its intended use.
• Post-Market Surveillance & Vigilance: We have comprehensive systems for monitoring performance in the real world, collecting user feedback, and promptly addressing any incidents.
• ISO 27001 (Information Security): Our ISO 27001 certification demonstrates our robust information security management system (ISMS), protecting patient data confidentiality, integrity, and availability. We strictly adhere to data protection regulations like GDPR.
• IEC 62304 (Software Lifecycle): We follow this standard for medical device software lifecycle processes, ensuring quality, reliability, and safety of our software components.