QMS Certification Assistance for Medical Device Manufacturers

QMS Certification is the official confirmation that your Quality Management System conforms to the requirements of an internationally recognized standard. For medical device manufacturers targeting the Russian market, this certification is a powerful tool that can streamline regulatory processes and demonstrate your commitment to quality

Relevant Standards:

• ISO 13485 «Medical devices — Quality management systems — Requirements for regulatory purposes» (the international industry standard).
• GOST ISO 13485 «Medical devices. Quality management systems. Requirements for regulatory purposes» (the Russian national adoption of ISO 13485, identical in content and structure).

For the purposes of medical device registration under national Russian rules, QMS certification must be obtained from a certification body accredited in the national accreditation system (Rosakkreditatsiya). A QMS certificate (ISO 13485 certificate) issued by an accredited body within a voluntary accreditation system will not be accepted by Roszdravnadzor during the registration process.

Timelines for QMS Certification:

Approximately 4 to 6 months

Our Service Fees for QMS Certification Assistance:

From $3 700

Achieve recognized QMS certification that satisfies Russian regulatory requirements. Partner with us for expert guidance through every stage of the process.