New G&H Life Sciences Innovation Hub in Rochester, NY, Awarded ISO 13485:2016 Certification for Quality Management of Medical Devices

As communicated on the official website of the International Organization for Standardization, “ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.”

The evaluation process started as an internal development project in August 2023, when an in-house expert team was formed with the goal of identifying the improvement areas needed for the ISO 13485:2016 certification requirements. After a thorough analytical phase, G&H has started working on the designated items. As such, with the preparatory actions set in motion, the actual certification process lasted only 4 months.

“The present certification for our Rochester facility represents the natural next step in our continuous development for life sciences,” says Steve Rowland, Quality Assurance & Regulatory Affairs Manager at G&H | ITL. “One can notice the surge in healthcare interest from past years, driven by a general health awareness of the global population. As such, G&H had to respond – not only by investing into this state-of-the-art life sciences innovation hub that we are putting on its feet in Rochester, New York, but also through an avenue that officially certifies our activity. That is why we chose to add G&H | ITL (US) to our ISO 13485:2016 certification process. G&H’s commitment towards sustainable, cutting-edge MedTech design and manufacturing can now be seen through this achievement, next to the vetted quality of our devices that our clients are fully benefitting from.”

The next steps of G&H | ITL (US) in terms of quality endorsements is to include its design capability within the ISO 13485:2016 framework. This is a process that has already been initiated, with an expected positive result coming in the first half of 2025. With the newly awarded quality status for manufacturing, servicing and repairing of medical devices, G&H | ITL (US) announces that it is ready for business within life sciences market in the United States, awaiting to partner up with clients who want to trailblaze the next generation of medical technology.