Company Overview
- Home
- Company Overview
We’re trusted by more than 350+ clients



Welcome to RAC Forge
About Us
Who We Are
RAC Forge is a premier global consultancy focused exclusively on regulatory affairs, quality management systems (QMS), and technical documentation for the medical device industry. Our multidisciplinary team offers deep expertise across diverse regulatory environments, supporting companies from product development to market entry and post-market surveillance.
What we are exceptional at
Our Services
Regulatory Strategy and Market Access
Expert advice for global medical device compliance.
India CDSCO (MDR 2017) Compliance
Expert advice for global medical device compliance.
US FDA Compliance
Expert advice for global medical device compliance.
EU MDR and EUDAMED Services
Quick, accurate FDA 510(k) submission assistance.
Global Regulatory Support
Support for CDSCO licenses and approvals.
Quality Management System (QMS) Services
Support for CDSCO licenses and approvals.
Technical Documentation Services
Technical files and regulatory documents prepared efficiently.
Labeling and IFU Development
Technical files and regulatory documents prepared efficiently.
Audit Support and NC Remediation
Identify and fix regulatory gaps quickly.
Training and Capacity Building
Clinical investigation plans and approval consulting.

Our Mission
Deliver expert regulatory and quality solutions that foster safe healthcare innovations and global market access.

Our Vision
Be the leading consultancy driving excellence in medical device compliance, enabling faster, safer delivery of healthcare technologies to patients around the world.
What Sets Us Apart
Why Choose RAC Forge?
- Global Expertise: Deep knowledge across CDSCO, US FDA, EU MDR, Health Canada, TGA, ANVISA, PMDA, and others.
- Tailored Solutions: Practical, customized strategies aligned to your product and target market.
- Proven Success: A strong record of successful regulatory approvals and audit outcomes.
- Client-Centric Approach: Transparent, proactive, and committed to your success.
- Future-Ready: Continuous monitoring of global regulatory changes to keep you compliant and competitive.
Call Us
+ 91-91400-91323


