Golden Helix Received ISO 13485:2016 Certification

         February 6, 2024

This month, we are excited to announce that we have received the certification for ISO 13485:2016 from TÜV SÜD. ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) for organizations involved in the design, development, production, and servicing of medical devices. It is specifically tailored to the medical device industry and is recognized globally as a benchmark for ensuring the quality and safety of medical devices.

In order to be certified, an organization has to maintain a quality management system, demonstrate sufficient risk management, and show consistent tracking of customer satisfaction and safety in the market as well as demonstrate continued improvement efforts on the product and system level.

We are very pleased to receive ISO 13485:2016 certification. It’s a testament to our efforts of continuous quality improvements, including our software development processes, customer success and support processes, and all other operational processes within our company. ISO 13485:2016 is designed to objectively document that we are holding ourselves to the highest quality standards as we are providing innovative solutions to hospitals, testing labs, and research institutions globally.

ISO 13485:2016 is crucial in the context of In Vitro Diagnostic Regulation (IVDR) because it ensures the safety and effectiveness of in vitro diagnostic devices (IVDs). It establishes quality management system requirements for IVD manufacturers, aligning with the IVDR’s regulatory framework. ISO 13485:2016 emphasizes risk management, documentation, traceability, competency, and continual improvement, all vital aspects of IVDR compliance.

In this context, it is very timely to note that the FDA issued the Quality Management System Regulation (QMSR) Final Rule on January 31, 2024. The QMSR rule emphasizes risk management activities and risk-based decision-making and aims to reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements, specifically through the adoption of ISO 13485. The rule amends the current good manufacturing practice requirements of the Quality System regulation in 21 CFR 820.

We are proud to be recognized for our efforts and will continue to strive for excellence in precision medicine.

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