GI Logic is honored to have received ISO 13485:2003 certification for the design and manufacture of its Acoustic Gastro-Intestinal Surveillance (AGIS) biosensor from the British Standards Institute (BSI). This important certification is the first step in achieving compliance with European regulatory requirements to sell the AbStats AGIS biosensor in countries outside the USA.
ISO 13485:2003 is an International Organization for Standardization (ISO) standard that represents the requirements for a comprehensive Quality Management System for the design and manufacture of medical devices. A copy of the GI Logic’s certificate can be viewed here.
Medical device industry specifics of this standard include:
- The promotion and awareness of regulatory requirements as a management responsibility. Examples of market-specific regulatory requirements include 21 CFR 820, the Quality System Regulation for medical devices sold in the United States, enforced by the U.S. Food and Drug Administration (FDA), or the Medical Devices Directive 93/42/EEC, required for doing business in the European Union.
- Controls in the work environment to ensure product safety.
- Focus on risk management activities and design control activities during product development.
- Specific requirements for inspection and traceability for implantable devices.
- Specific requirements for documentation and validation of processes for sterile medical devices.
- Specific requirements for verification of the effectiveness of corrective and preventive actions.
Compliance with ISO 13485 is the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to European Union Directives 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The preferred method to prove conformity is the certification of the Quality Management System by a Notified Body. The result of a positive assessment is the certificate of conformity allowing the CE mark and the permission to sell the medical device in the European Union and other markets outside of the U.S.
“Receiving this ISO 13485 certification marks a significant achievement in the development of the AbStats digestive monitoring system and is a testament to the skill and dedication of our research team of doctors and engineers,” said James Beeton, CEO of GI Logic.
“With this certification now in place, we look forward to working toward further regulatory approval that will enable us to commercialize our AbStats system using low cost, non-invasive sensors that will greatly enhance patient care while reducing hospital cost.”
About GI Logic
GI Logic founded in late 2013 was created to address an urgent unmet need for a convenient, low cost, non-invasive system that can be deployed rapidly in the hospital, clinic and home for monitoring and diagnosis of digestive disorders. Through innovation and research, GI Logic will continually evolve medical devices that help contribute to human welfare and advance the field of gastroenterology.