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.
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.

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+ 91-91400-91323

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