Medical device certification to streamline quality
ISO 13485 is the internationally recognized quality management systems standard for the medical device industry. The medical device business is grounded in trust. Before a device is used on a patient, it must first win the trust of many stakeholders. From medical staff, hospitals, and healthcare institutions to regulators and often the public themselves.
A quality management system is integral to this chain of trust. It ensures that your medical products consistently meet customer expectations of quality, safety, and performance.
In some markets, such as the European Union, Canada, and Japan, medical device manufacturers must implement and obtain certification of quality management (QM) system according to ISO 13485.
The ISO 13485:2016 edition of the standard builds on the ISO 9001:2008 standard includes additional regulatory requirements for the medical device industry. Following the last revision, this third edition of March 1, 2016, incorporates 12 years of technological progress and global regulatory changes.
In view of the above, manufacturers and service providers in the medical device industry are facing changed and extended requirements. A summary of the key changes:
In the EU, the requirements of ISO 13485 have been harmonized with the essential requirements of the EU’s Medical Device Directive (93/42/EEC), the Directive for In Vitro Diagnostic Medical Devices (98/79/EC) and the Directive for Active Implantable Medical Devices (90/385/EEC). Certification to ISO 13485 by an accredited certification body provides a presumption of conformity with the essential requirements of these important directives.
In the U.S., the Food and Drug Administration (FDA) permits device manufacturers to submit ISO 13485 audit reports as a substitute of the evidence of compliance with its quality systems regulations (QSR). Health Canada also requires medical device manufacturers marketing their products in Canada to have their quality management system certified to ISO 13485.
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. We know how to assess your operational efficiency.
To help you estimate the individual efforts involved in your implementation of ISO 13485:2016 and prepare for the change in the best possible way, TÜV SÜD will provide you with basic information related to the standard. Our factsheet, which is available for download here, summarizes the information at a glance.
TÜV SÜD offers a complete range of testing, certification, and auditing services to manufacturers of medical devices. Our specialists and experts will be happy to answer any further questions you may have.
Fulfill the requirements of ISO 13485:2016 with expert guidance
A quick guide to the revised ISO 13485:2016 standard
Discover the similarities and differences between the two standards
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