Medical Devices Regulatory Services

CE Marking for Surgical face masks

CE Marking

CE mark for Surgical Face mask as Class I medical device from EAR after Testing as Per EN 14683:2005

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UK Responsible Person

UK Responsible Person

We  as UK Responsible person  established in the United Kingdom   acts on behalf of a manufacturer under UK MDR 2019

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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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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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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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