Regulatory Quality - Robust & Effective Quality Management System

Response Biomedical Corp. (“Response”) operates on a strong Quality Policy mandate to maximize customer satisfaction and exceed their expectations, driven by a company-wide commitment to continual improvement and supported by effective compliance with global requirements.

Quality System

Highest Manufacturing
& Quality Control Standards

Response’s RAMP® products are manufactured under ISO 13485, European In-Vitro Diagnostic Directive 98/79/EC, Canadian Medical Device Regulations, Japanese Manufacturing & Quality Control standards and the US-FDA Quality System Regulation.

International Certifications

Response holds current ISO 13485:2003 and ISO 9001:2008 certifications. ISO 13485:2003 is an internationally recognized standardization system for the design, development, manufacturing and distribution of medical devices. The certification confirms that Response has successfully implemented a quality system that conforms to the exacting standards of the International Organization for Standardization (ISO) for medical devices.

Response’s ISO 13485 compliant Quality Management System is required by European regulators. RAMP® products are CE marked and distributed throughout Europe. A CE Marking is a European marking of conformity that indicates a product complies with the essential requirements of applicable European laws or directives with respect to safety, health, environment and consumer protection.