RAC Forge
RAC Forge
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+ 91 62396 99077

Expert Medical Device
Regulatory Consulting
for Global Market Access
 View Our Services Get Regulatory Consultation Navigating CDSCO, USFDA, and EU MDR Compliance with Precision and Expertise
Who we are

Your Global Medical Device Regulatory Partner

RAC Forge is a leading regulatory consultancy that focuses on Medical Devices compliance in major global markets. We provide strategic guidance and thorough documentation services to help manufacturers successfully navigate complex regulations in India, the United States, and the European Union. Our expertise lies in crafting the detailed technical documentation needed for regulatory approvals while ensuring compliance with CDSCO's Indian MDR (Medical Devices Rules 2017), USFDA requirements, and the EU MDR 2017/745.
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Core Services

CDSCO India

  • Manufacturing License Applications (MD-3, MD-5, MD-7, MD-9)
  • Import License for Commercial Sale (MD-14, MD-15)
  • Loan License Applications (MD-4, MD-6, MD-8, MD-10)
  • Test License Permissions and Novel Device Approvals (MD-16, MD-17)

USFDA

  • 510K USFDA Premarket Notifications with eSTAR
  • PMA (Premarket Approval) Applications
  • FDA De Novo Classification Requests
  • Quality System Regulation Compliance (ISO 13485)

EU MDR

  • Manufacturing License Applications (MD-3, MD-5, MD-7, MD-9)
  • Import License for Commercial Sale (MD-14, MD-15)
  • Loan License Applications (MD-4, MD-6, MD-8, MD-10)
  • Test License Permissions and Novel Device Approvals (MD-16, MD-17)
Why Choose

RAC Forge

In-depth Regulatory Knowledge

Strong understanding of CDSCO, USFDA, and EU MDR requirements.

Documentation Quality

Specialized in creating submission-ready technical documents, including Risk Analysis and Biological Evaluation.

Strategic Focus

Planning regulatory pathways and managing risks through robust Risk Management.

Proven Success

Successful submissions across all device categories, from Class A medical Device to Class D Medical Device..

Client-Focused Service

Customized support throughout the regulatory process.
What Makes Us Different

Strategic Regulatory Consulting Without Physical Testing

We specialize in strategic regulatory consulting and creating documentation packages to meet every Essential Requirement without conducting physical product testing.

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