MS Certification Services

GHOST-R

Ensure Seamless Compliance with GHOST-R Certification

At Alpine Quality Consultants, we offer expert consultancy services to help medical device manufacturers achieve GHOST-R certification—a mandatory regulatory requirement for medical devices entering the Russian and Eurasian Economic Union (EAEU) markets. Our comprehensive services ensure that your products meet the strict quality and safety standards outlined in the GOST-R regulations, allowing for a smooth market entry.

What is GHOST-R Certification?

GHOST-R certification (often referred to as GOST-R) is a quality and compliance certification required for medical devices in Russia and the EAEU region. It validates that your products comply with local safety, quality, and performance regulations.

Depending on the product type, certification may be mandatory or voluntary, and it plays a crucial role in ensuring regulatory approval for medical devices in these regions.

Our Consultancy Services

We provide a structured, step-by-step approach to obtaining GHOST-R certification, including:

Regulatory Assessment & Compliance Strategy

  • Determination of product classification and applicable GOST-R requirements
  • Identification of necessary documents and regulatory pathways
  • Customized compliance roadmap for certification success

Technical Documentation Preparation

  • Assistance in preparing and reviewing technical files, user manuals, and labelling
  • Compilation of product test reports and safety evaluations
  • Compliance with Russian and EAEU regulatory documentation standards

Testing & Certification Coordination

  • Coordination with accredited Russian testing laboratories
  • Product performance and safety testing support
  • Guidance on clinical evaluations and risk assessments

Application Submission & Certification Support

  • Preparation and submission of certification applications
  • Liaising with Russian regulatory bodies for smooth approvals
  • Assistance with obtaining Declaration or Certificate of Conformity

Post-Certification Support

  • Assistance with periodic renewals and regulatory updates
  • Market surveillance and compliance monitoring
  • Continued support for modifications and product extensions
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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