Medical Device

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The Medical Device Industry

The medical device industry is required by the FDA to establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (including pharmaceuticals, foods, and medical devices) are known as current good manufacturing practices (CGMP’s). For devices, the key CGMP requirements are embodied in 21 CFR part 820. The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. Manufacturing facilities undergo FDA inspections to assure compliance with the CGMP requirements.

The scope of inspections encompasses not only the medical device company, but also the contract testing laboratory used by the medical device company. Thus, even if a manufacturer is complying with CGMP within their own facility, the manufacturer may still have responsibility for the deficiencies of the outsource testing laboratory. For this reason, medical device companies should make a conscious effort to trust only quality-centric contract CGMP analytical chemistry laboratories like Global Pharma Analytics.

Unlike pharmaceutical regulations, the CGMP regulation for medical device is designed to have some similarities with ISO 13485 as part of a deliberate push toward international harmonization. Like the CGMP for drugs, medical device CGMP, “embraces the same “umbrella” approach to the CGMP regulation that was the underpinning of the original CGMP regulation. Because the regulation must apply to so many different types of devices, the regulation does not prescribe in detail how a manufacturer must produce a specific device. Rather, the regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device.” 1.

Because of this inherent flexibility, medical device companies should use good judgment when selecting a contract CGMP analytical chemistry laboratory. Medical device companies carry the responsibility that the products they produce are safe and effective. The FDA states, “The responsibility for meeting these requirements and for having objective evidence of meeting these requirements may not be delegated even though the actual work may be delegated.” 1. Thus, the medical device company should only work with quality contract CGMP analytical laboratories like Global Pharma Analytics.

Global Pharma Analytics has worked with many medical device clients. We pride ourselves in being experts within the testing arena for contract CGMP analytical chemistry testing services for medical device companies. While this may be a bold statement, because of our track-record of success with medical device clients, we know the statement to be true. We currently serve medical device companies from start-ups to multi-billion dollar international organizations. Thus, for a medical device company needing contract CGMP analytical chemistry testing services, Global Pharma Analytics should be the first choice.

1. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm#qs

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