medical device classification services
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FDA Medical Devices: Definition and Classifications Services
All medical devices in the United States are regulated by the Food & Drug Administration (FDA), and understanding the FDA’s definition of a medical device as well as how the agency classifies medical devices is a crucial part of learning how to bring your medical ...
By in2being, LLC based in Saline, MICHIGAN (USA).
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Medical Disinfection Services
Disinfection is the process by which microorganisms are destroyed in order to prevent transmission to the next patient via a medical ...
By Nanosonics, Inc. based in Sydney, AUSTRALIA.
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Spaulding Classification Services
Earle H. Spaulding recognised a disinfection framework was required since all reusable medical devices cannot be sterilized. The Spaulding Classification met a key unmet need that today still forms the basis of international medical device disinfection ...
By Nanosonics, Inc. based in Sydney, AUSTRALIA.
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Consulting Services
IDG helps you approach the medical device market with ease of mind. We assist you with Medical Device and IVD Registration, local in-country representation, distributor qualification and quality system ...
By Integrated Diagnostics Group, A division of Sanzay Corporation based in Miami Gardens, FLORIDA (USA).
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Medical Device Testing Services
Careful attention to product compliance and certification are an integral part of the process of developing and marketing medical devices. Certifiers, regulators,and standards-writing bodies such as Underwriters Laboratories (UL), the Canadian Standards Authority, the IEC and the FDA have been working hard to keep ...
By Product Safety Consulting, Inc. based in Bensenville, ILLINOIS (USA).
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STEMart - Notified Body (EU) Services
CE marking is the manufacturer's declaration that their product complies technically and administratively with the essential regulatory requirements of Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC, Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and In ...
By STEMart based in Shirley, CALIFORNIA (USA). from Medical Device Development Service - Medical Device Certification Services Service line
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Medical Device Regulation Services
The Food and Drug Administration (FDA) regulates all medical devices in the United States to make sure they are safe and effective. These regulations are a critical part of the medical device development process, and they will likely influence the design and testing of new medical devices. ...
By in2being, LLC based in Saline, MICHIGAN (USA).
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