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As the international standard for Quality Management Systems in the medical device industry, ISO 13485 has already been tested and proven.

Companies that have achieved certification can show proof to potential clients that they comply with best practices, and with regulatory requirements. And, along the way, your company will naturally enjoy better control over its processes, and continual improvement – driving continual ROI.

In 2018, the U.S. Food and Drug Administration (FDA) – the government department that regulates the medical devices sector – announced its intention to use ISO 13485 as the basis for its quality system legislation.

A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.

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.

Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. ISO does not perform certification.

The medical devices industry is one of the most highly regulated sectors in the world. Significant quality systems and product requirements must be satisfied to ensure the medical devices produced are fit for their intended purpose. 

Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.

Internationally agreed standards set out the requirements for a quality management system specific to the medical devices industry. 

Want to learn more? Tonex offers FDA cGMP, QSR and ISO Certifications for Medical Devices, a 3-day course that is intended to help medical device and IVD manufacturers implement quality systems that meet the GMP/QSR/ISO 13485 and ISO 14971 and IEC 62304 standards by providing training and consulting. 

For more information, questions, comments, contact us.

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