ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

As an internationally recognised standard of quality and safety for medical device manufacturing, having ISO 13485 certification helps companies get recognised as more reputable, trustworthy providers.

5 days ago · ISO 13485 certification exists for companies and for individuals - learn what the difference is, and what you need to finish to get ISO 13485 certified

ISO 13485:2016 is the standard for a Quality Management System (“QMS”) for the design and manufacture of Medical Devices. Certification to the standard requires an organization’s quality management system to pass a third-party Medical Device Single Audit …

Achieving ISO 13485 certification proves that your medical devices have been manufactured under a certified quality management system. Our auditors have an established history of assessing leading medical device manufacturers with ISO 13485 audits and certification.

Jan 25, 2024 · To get ISO 13485 certification, companies must first develop a QMS that meets the standard’s requirements. This involves establishing processes and procedures that ensure product safety and efficacy. The next step is conducting internal …

ISO 13485 is an internationally recognized standard that outlines the requirements for a quality management system tailored specifically for medical devices. It ensures that manufacturers consistently meet customer and regulatory requirements, which is …

Jun 8, 2022 · Achieving either ISO 13485 or ISO 9001 certification is seen as the first step to approval for a medical device in Europe. Beyond earning regulatory approvals, following the ISO 13485 standard can produce higher quality medical devices.

Jul 12, 2024 · What is ISO 13485 Certification? An ISO 13485 certification is a way to exhibit an organization’s compliance with the ISO 13485 standard created by the International Organization for Standardization (ISO) for the medical device manufacturing industry.

May 31, 2023 · Learn about the requirements for a quality management system in the medical device industry. The ISO 13485 certification standard is an internationally recognized standard that stipulates regulations for a quality management system (known as a QMS) in the field of medical devices.