Safety standards and product testing

Product safety is an important issue for medical device companies. Before a manufacturer can submit a 510(k) application for market clearance of his product in the USA, he has to prove that the product is safe and effective. Safety is usually proved through a combination of literature studies and testing. Product safety testing can take many forms, depending on the nature of the product. Virtually all devices must be subjected to a risk management program; BesTech uses the internationally recognized ISO 14971:2007 standard for this program. Electrical devices must comply with the EN/IEC 60601 safety standard series; this includes Electromagnetic Compatibility (EMC) testing. Devices with included software must comply with the requirements of “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” for off-the-shelf software, and “General Principles of Software Validation; Final Guidance for Industry and FDA Staff” for home-grown software; all published by the FDA. Devices that are implantable, be it short-term ("transient") or long-term, must comply with many provisions regarding construction, biocompatibility, and sterility.

Medical devices to be exported to the European Union must comply with the "Medical Device Directive", a set of regulations similar to those mandated in the USA, to obtain the CE-mark.

BesTech can decide which tests to carry out, and take care of the complete program, working with renowned local and national test laboratories. BesTech can also guide you with respect to product effectiveness testing, usually accomplished through clinical testing. The FDA sometimes requires clinical testing in cases where the effectiveness of a device is not readily evident to the reviewer, for example in case of a new application of an existing technology.

FDA consulting · CE-marking · Medical device consulting · Product development · Medical device safety testing