ReNew Biomedical is proud to announce that we have been awarded the International Organization for Standardization’s Medical Device Quality Management System (MD QMS) certification ISO 13485:2016. MD QMS 13485 is a widely-recognized international standard, setting guidelines for the best practices to develop an efficient Quality Management system for the safety and quality of medical device care. Created in 2016, the ISO 13485 standard was reviewed and upheld in 2020, ensuring the standard remains current.
ReNew has been ISO 9001:2015 certified since 2017 but has now upgraded to the ISO 13485:2016 standard. While the 9001 verified our general quality management system, the 13485 standard sets rigorous guidelines explicitly meant for the medical device industry. ReNew Biomedical, as a medical device service and repair company, meets the latest medical quality management system standards while also focusing on customer satisfaction.
“Obtaining ISO 13485 certification is not an easy process. ReNew Biomedical’s attempt to raise the bar in our industry demonstrates our commitment to our customers,” Says Jill Taylor, co-owner of ReNew. “We take pride in our abilities and willingness to learn, refine and improve our processes. We know that lives depend on medical artillery that is operating to manufacturer’s standards and guidelines.”
The most important consequence of ISO 13485 certification is protecting consumers’ health by reducing the risk of defective devices. ReNew works hard to improve operational efficiency and minimize the risks for safety faults and failures while reducing costs associated with poor service compliance.
As the healthcare industry continues to fall under intense scrutiny, biomedical service companies must comply with higher standards, and ISO certifications, such as the 13485:2016, have become a prerequisite to doing business. It is vital to enter agreements with a company vetted by an unbiased third party and commited to consistently improving in specific areas. Companies with ISO certifications routinely enhance internal efficiency, enabling them to increase operational capacity and make fewer mistakes, both of which result in a better product or service for practitioners and their patients.
Josh Kasper
Lead Marketing Designer, ReNew Biomedical
August 30, 2021
