HOW CAN WE HELP YOU

Comprehensive Regulatory and Compliance Services for Global Presence

HOW CAN WE HELP YOU

Comprehensive Regulatory and Compliance Services for Global Presence

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01.

Representation Services

Authorized legal representation services in various jurisdictions to ensure ongoing compliance and communication with local authorities.

As authorized representatives in each region, we act as your primary point of contact with local authorities, ensuring smooth communication and continuous regulatory compliance.

02.

FSC

The Free Sale Certificate (FSC) is an international document used for exporting medical devices and IVD products.

We assist you with the issuance of Free Sale Certificates from key countries, facilitating the export and registration of products internationally.

03.

CRO

Clinical evaluation is the final validation of a medical device to confirm that it functions as intended and can be safely used on patients according to its instructions for use.

Our CRO services provide comprehensive solutions to accelerate the approval of your products.

04.

Consulting Services

A compliant medical device technical file is essential for obtaining and maintaining market authorization for the device in the European Union.

The technical documentation for IVDR is essential as it contains the compilation of supporting information about your in vitro diagnostic medical device (IVD).

At CMC, we can help you establish your quality management system according to ISO 13485:2016.

CMC will validate your registration in EUDAMED as an EC REP and assist you at every step of the actor registration and device registration process.

05.

Other Representation Services

Our representation services at CMC go beyond standard consulting.

We specialize in acting as your representative in key negotiations, managing strategic relationships with stakeholders, and facilitating the expansion of your business network.

06.

Global Registration

In CMC, we offer comprehensive global registration services that facilitate the entry of your products into regulated international markets such as Europe, UK, Switzerland, Australia, USA, China, Saudi Arabia, Korea, and India.

Trust CMC to simplify and expedite your international expansion with our expert global registration services.