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for Medical Devices
At RAC Forge, we specialize in guiding medical device companies through the complexities of global regulatory compliance. Whether you're entering the Indian market through CDSCO, seeking FDA approval, navigating EU MDR and EUDAMED requirements, or expanding globally, we deliver precise, comprehensive, and results-driven solutions.
- Global regulatory compliance partner
- CDSCO and FDA 510(k) experts
- Tailored regulatory consulting solutions
- Proven success across device types
We help medical device companies navigate complex regulatory processes with clarity, precision, and confidence — ensuring faster approvals and market success.
Get in Touch
+ 91 91400 91323
At RAC Forge, we combine deep regulatory expertise with hands-on industry experience to help your medical devices achieve faster approvals and stronger compliance. Our client-focused solutions are designed to maximize success at every step of the regulatory journey.
Affordable
Cost
Cost
Quality
of Work
of Work
Our team designs customized regulatory plans based on your product type, target markets, and business goals, ensuring a smooth and compliant path to approval.
From technical files to 510(k) submissions, we offer complete documentation solutions that meet all CDSCO and FDA requirements with precision and clarity.
We navigate complex global regulations, helping your products gain approvals across multiple regions while maintaining the highest standards of quality and safety.
Regulatory-Insights
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Documentation Services
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Regulatory Solutions
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Technical Documentation
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"RAC Forge made our FDA 510(k) submission seamless. Their expertise saved us months!"
Nancy Chopra
MedTech Solutions, Mumbai, India
"Their support with CDSCO licensing was outstanding. Highly professional and reliable."
Andrew Smith
Regulatory Affairs Manager, Boston, USA
"Thanks to RAC Forge, our technical file met every regulatory requirement on the first review."
Lukas Hoffmann
QA/RA Specialist, Berlin, Germany
"RAC Forge's consulting services helped us scale our devices across multiple markets effortlessly."
David Anderson
Meditech Global, Singapore
Global Regulatory Expertise
We partner with companies worldwide to navigate CDSCO, MDR-2017, and FDA requirements with precision.
Powered by Industry Knowledge
Our team brings deep regulatory experience, ensuring tailored solutions and smooth market access.
Jessica Brown
Consultant
VIkas Sharma
Senior Regulatory Consultant
Christina Eve
Technical Documentation Lead
Rajesh Verma
Regulatory Affairs Director
Fred Andrew
Consultant
08
Dec
Understanding the Difference Between CDSCO and FDA Regulations for Medical Devices
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08
Dec
Top 10 Common Mistakes to Avoid in Medical Device 510(k) Submissions
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08
Dec
India Medical Device Rules (MDR-2017) Explained: What Manufacturers Need to Know
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08
Dec
How to Get CDSCO Approval for Medical Devices: A Step-by-Step Guide
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08
Dec
Why Technical File Preparation Is Critical for Medical Device Approval
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