Medical Devices

Standards Certifications for Medical Devices

When it comes to the devices that can save lives and improve health, standards certifications are unquestionably critical. Orion Assessment can facilitate accreditation for required standards for manufacturers of medical devices, as suited to a variety of markets.

The international standard for medical devices is ISO 13485, and is applicable to not only manufacturing, but also design and tracking. From concept to ongoing inspection capabilities (i.e. for devices that are implanted in patients), medical devices have a set of specifications that are unique, such as sterilization.

For manufacturers planning to market their product in Europe, another standard may need to be considered. CE Marking is a standard set forth by the European Commission and may be required in many European countries.

Orion Assessment is a knowledgeable partner who can help you to achieve the standards certifications you need to operate and expand your business in your primary markets. Contact us today for more information.

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