Regulatory Solutions

Expert consultancy for medical device regulatory compliance and documentation.

A blue protective face mask with a white print displaying certification details, including CE marking and standards compliance. The mask features ear loops and a structured design.
A blue protective face mask with a white print displaying certification details, including CE marking and standards compliance. The mask features ear loops and a structured design.
CDSCO Documentation

Preparation and submission of regulatory filings for devices.

A person is holding a medical device, specifically an automated external defibrillator (AED), with a red accent and labeled 'iPAD'. The device has a screen, control buttons, and an on/off switch. The hallway setting in the background includes tiles on the floor.
A person is holding a medical device, specifically an automated external defibrillator (AED), with a red accent and labeled 'iPAD'. The device has a screen, control buttons, and an on/off switch. The hallway setting in the background includes tiles on the floor.
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A medical professional wearing protective gear and magnifying glasses is performing a procedure. The setting is brightly lit, highlighting the focus on the detailed work being done. Instruments and gloved hands are visible, indicating a clinical environment.
A medical professional wearing protective gear and magnifying glasses is performing a procedure. The setting is brightly lit, highlighting the focus on the detailed work being done. Instruments and gloved hands are visible, indicating a clinical environment.
A person wearing full protective medical gear and a face shield is holding a clipboard and pen in a tent-like environment. Various equipment and items are scattered on tables in the background.
A person wearing full protective medical gear and a face shield is holding a clipboard and pen in a tent-like environment. Various equipment and items are scattered on tables in the background.
510(k) Submissions

Assistance in drafting documents for FDA approval submissions.

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Get in touch for regulatory consulting and documentation support.

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Expert regulatory consulting for medical device compliance.

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info@racforge.com

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