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Expert Regulatory Solutions for Medical Devices

Navigating compliance with ease through our comprehensive services.

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Regulatory Consulting

Expert guidance on CDSCO and FDA requirements.

CDSCO Documentation

Preparation and submission of regulatory filings efficiently.

510(k) Submissions
Technical File

Your Partner in Compliance

At RAC Forge, we specialize in regulatory consulting and documentation services for the medical device industry, ensuring compliance with CDSCO and FDA requirements.

A medical device is positioned against a plain background. The machine features a screen displaying various icons and controls, likely for diagnostic purposes, and an apparatus for eye examination.
A medical device is positioned against a plain background. The machine features a screen displaying various icons and controls, likely for diagnostic purposes, and an apparatus for eye examination.
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A medical device with a digital screen is centrally positioned. It is surrounded by a booklet, a package of medical supplies, and a power cable with an adapter. The booklet and package feature text.
A medical device with a digital screen is centrally positioned. It is surrounded by a booklet, a package of medical supplies, and a power cable with an adapter. The booklet and package feature text.
A medical imaging device with a monitor displaying a user interface featuring multiple icons and buttons. The device is labeled 3D OCT Maestro by Topcon. There is also a black adjustable arm and other medical supplies in the background.
A medical imaging device with a monitor displaying a user interface featuring multiple icons and buttons. The device is labeled 3D OCT Maestro by Topcon. There is also a black adjustable arm and other medical supplies in the background.

About RAC Forge

We provide expert guidance and comprehensive support for regulatory submissions, including 510(k) submissions and technical file preparation, simplifying your compliance journey.

Regulatory Solutions

Expert guidance for navigating medical device regulatory complexities with comprehensive documentation and consultancy services.

A person wearing a smartwatch writes on a notepad while using a tablet that displays medical images. A stethoscope is positioned close by on a white desk, suggesting a medical setting.
A person wearing a smartwatch writes on a notepad while using a tablet that displays medical images. A stethoscope is positioned close by on a white desk, suggesting a medical setting.
An assortment of medical equipment including monitors, dials, and gauges is present, possibly used for anesthesia or patient monitoring in a healthcare setting. There are various knobs and labels indicating settings for oxygen and nitrous oxide management. A tray contains a packaged medical device labeled 'Hand Piece.'
An assortment of medical equipment including monitors, dials, and gauges is present, possibly used for anesthesia or patient monitoring in a healthcare setting. There are various knobs and labels indicating settings for oxygen and nitrous oxide management. A tray contains a packaged medical device labeled 'Hand Piece.'
Consulting Services

Expert guidance on CDSCO and FDA requirements tailored for the medical device industry.

Documentation Support

Preparation and submission of regulatory filings, including device registrations and import licenses for compliance.

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Contact us for expert regulatory consulting and documentation services tailored for the medical device industry. We're here to assist you.

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