Medical Devices Regulatory Services

US FDA Services

US FDA Registrations

Prior to exporting a Medical device in US it must be registered with US FDA . We Register both 510K exempt and 510K products with US FDA

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Free Sales Certificate

Free Sales Certificate (FSC)

We provide Free Sales certificate (FSC) from EU-European Union  country and UK  for medical Devices from with apostle service.

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EAR Services-(EU)

Authorized Representative

We  monitor vigilance issues related to your product and are the contact person on your behalf for European authorities

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ISO 13485:2016

ISO 13485:2016

ISO 13485 states the international standard requirements for a QMS specifically aimed for medical devices.

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ISO 9001:2015

ISO 9001:2015

ISO 9001 helps organizations to ensure that high quality products and services  is provided to their customers consistently, which in turn brings satisfied of customers as well as of management, and employees.

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CE Marking

CE Marking

CE mark is a kind of compliance mark for placing your product in EU market. It opens the doors for all the 28 major countries of EU for the device and also symbolizes the highest level of product quality.

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IEC 60601

IEC 60601 Pretesting

The IEC 60601-1 addresses risks associated with electronic medical devices –this standard has become a de facto requirement for most companies manufacturing electro-medical equipments.

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