Medical Device Consultants

Modern health care  across all continents depends on the use of sophisticated devices for patient care and cure. Unlike drugs the  primary mode of action of devices is not pharmacological, immunological or metabolic. 
Manufacturing or Marketing of medical devices are controlled by regulatory authorities in each country. The major medical device markets are USA, Europe, India, China, Canada, Russia, Brazil.

  • US FDA's Centre 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

More information about Medical Device 510k clearance process, Establishment Registration and listing Refer here. We are Medical Device Consultants with good knowledge and exposure in US FDA regulations in all class of devices.

  • European Regulations covering 28 member countries and 5 Candidate countries relating to the safety and performance of medical devices following below directives.

Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD
Council Directive 93/42/EEC on Medical Devices (MDD
Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVD)
Marketing medical device in Europe is allowed only after affixing CE Mark. Marketing Medical device in USA is allowed only after establishment registration and product listing.
Our one-stop shop approach offers a wide range of services designed to help export of medical devices to  USA and Europe fast.
In search of Medical Device Consulting service or for any clarification customers can fill our contact form, we are happy to help you.

INDIA -Bangalore
+ 91 994 591 2081
Phone / Viber / WhatsApp

USA -Chicago
+1 630 696 1293
Phone / Viber / WhatsApp

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