ISO 13485: 2016 – Medical Devices
ISO 13485: 2016 Medical Devices – 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.