QUALITY MANAGEMENT

ISO 13485: 2016 – Medical Devices

ISO 13485: 2016 Medical Devices – Quality Management System

The ISO 13485: 2016 Quality Management System for Medical Devices specifies requirements for a company to show its ability to provide medical devices that consistently meet regulatory requirements while fulfilling customer needs. The standard can be applied to one or more stages of the product life cycle, covering anything from design and development to production and distribution. Requirements for storage, installation and servicing of medical devices are also covered under the ISO 13485 standard, as are associated issues such as technical support. In addition to manufacturers, suppliers and distributors who provide products used in the manufacturing of medical devices can also use the ISO 13485 quality management system.

Companies Who Reap the Benefits of ISO 13485.

Any company involved in the design, production and manufacturing, installation and servicing of medical devices can use ISO 13485 to demonstrate their commitment to consistently providing safe, high-quality products and services. Although ISO does not require certifications for the ISO 13485, third-party audits and certification can show regulators that your company is in compliance and meets the ISO 13485 standard.

Determining if Your Product is Classified as a Medical Device.

According to the FDA, a product is classified and defined as a medical device as follows:

“An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).”

The ISO 13485: 2016 standard is an important Quality Management System for any company involved in the manufacturing of medical devices. Missouri Enterprise’s ISO Project Managers can help you with ISO 13485 and many other ISO standards and certifications. Contact your local Missouri Enterprise Area Business Manager to learn more.

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