Regulatory Solutions

Expert guidance and comprehensive documentation for medical device compliance.

Two people in lab coats collaborate in an office setting. One is seated and pointing at a computer screen displaying medical images, while the other stands nearby holding a tablet. Large windows reveal a view of greenery outside, creating a bright and professional environment.
Two people in lab coats collaborate in an office setting. One is seated and pointing at a computer screen displaying medical images, while the other stands nearby holding a tablet. Large windows reveal a view of greenery outside, creating a bright and professional environment.
Regulatory Consulting

Guidance on CDSCO and FDA requirements for devices.

A sign featuring the word 'CONSULTATION' in bold, black capital letters. Beneath the text, there is Braille marked on a white background, surrounded by a dark wooden frame.
A sign featuring the word 'CONSULTATION' in bold, black capital letters. Beneath the text, there is Braille marked on a white background, surrounded by a dark wooden frame.
CDSCO Documentation

Preparation and submission of regulatory filings for devices.

A hand wearing a latex glove is holding a medical device with a small needle and a pink-colored cap.
A hand wearing a latex glove is holding a medical device with a small needle and a pink-colored cap.
A gloved hand holds a sterile medical device, possibly for blood testing or sample collection, with a green and black background.
A gloved hand holds a sterile medical device, possibly for blood testing or sample collection, with a green and black background.
510(k) Submissions

Remote assistance with drafting FDA approval documents.

Technical Files

Complete support for regulatory submission documentation needs.

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RAC Forge provided exceptional guidance through the regulatory maze, making our FDA submission process seamless and stress-free. Highly recommend their expertise!

Rohit Singh

A person wearing blue gloves is applying a gel from a bottle onto a medical device, possibly an ultrasound probe, indicating preparation for a medical procedure.
A person wearing blue gloves is applying a gel from a bottle onto a medical device, possibly an ultrasound probe, indicating preparation for a medical procedure.

★★★★★

Solutions

Expert regulatory consulting for medical device compliance.

Support

Consultancy

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