GOST 13485-2017 (ISO 13485:2016)
GOST 13485 "Medical devices — Quality management systems — Requirements for regulatory purposes" is an internationally harmonized standard establishing quality management system requirements specific to the medical device industry.
GOST 13485-2017 (ISO 13485:2016) Certification: Quality Assurance and Access to New Markets
"Expert GRUPP" offers professional services for the certification of medical device quality management systems in accordance with the GOST ISO 13485-2017 (ISO 13485:2016) standard. This international standard defines the requirements for a QMS for medical device manufacturers. Certification to ISO 13485 confirms your product's compliance with leading global practices and guarantees high quality.
Why is GOST 13485 Certification Necessary?
ISO 13485 certification confirms that your QMS meets international quality standards and opens new opportunities for the development of your business.
Why is GOST 13485 Certification Necessary?
ISO 13485 certification confirms that your QMS meets international quality standards and opens new opportunities for the development of your business.
Benefits of GOST 13485 Certification:
- Expanded Market Access: Access to new markets, including international ones, thanks to the global recognition of the ISO 13485 standard.
- International Collaboration: Compliance with the requirements of foreign partners and simplified interaction with international organizations.
- Competitive Advantage in Tenders: Priority when participating in government and commercial procurement of medical devices.
- Conformity Marking: The right to mark products with the ISO 13485 conformity mark, which increases consumer confidence.
- Increased Profitability: Strengthening reputation, increasing competitiveness, and boosting sales.
- Process Optimization: Improving production efficiency and reducing risks associated with product quality.
"Expert GRUPP" – Your Reliable Partner in Medical Device Certification!
Certification Procedure:
