Synaptive Quality Statement

Synaptive Medical is a MDSAP, ISO 13485 registered company. We are committed to providing exceptional quality in our products and services, and we actively listen to feedback from our customers and medical professionals to ensure optimum product performance in diagnostic imaging and the operating room. All products offered for sale meet IEC 60601 standards for safety and electromagnetic compatibility. In addition, ISO 14971 (risk control standard) is applied from design and development to final delivery.

BSI Certificate of Registration for Synaptive Medical Inc. certifying conformity with ISO 13485:2016 quality management system, effective from 2025-09-11 to 2027-05-07.BSI Certificate of Registration for Synaptive Medical Inc. certifying ISO 13485:2016 compliance for design and servicing of medical imaging and surgical software and systems, signed by Graeme Tunbridge.EU Quality Management System Certificate issued by BSI to Synaptive Medical Inc., detailing manufacturer and authorized representative addresses, scope, issue and expiry dates, and signed by Graeme Tunbridge.