QUALITY

Medical Murray provides our customers with the highest level of quality required for medical devices. All of our manufacturing services comply with FDA QSR 21 CFR – Part 820 and certified to ISO 13485:2003 for design and manufacturing of Medical Devices.

To ensure we maintain our quality standards, we are audited by an independent third party auditor each year. Our current ISO 13485:2003 Certificate of Registration for the “Design, Development, and Analysis of Medical Devices along with Component Manufacturing and Assembly of Medical Devices” can be viewed in pdf format at www.medicalmurray.com/PDFs/iso13485_06132014.pdf

Medical Murray’s cleanrooms are compliant with ISO 14698, Cleanrooms and associated controlled environments - Biocontamination control and ISO 14644, Cleanrooms and associated controlled environments. They are maintained at an ISO Class 7 level.

Medical Murray’s Quality team is dedicated to ensuring that the devices we manufacture are of the highest quality. They are involved in the development stages of all projects to help identify and develop quality requirements, test methods and inspection requirements that are used to validate new products prior to full production. This continued support is valuable to ensure a smooth transition into full production.