ISO 13485 | Medicine

The international industry standard ISO 13485 specifies requirements for a quality management system of enterprises involved in the chain of medical equipment. Its use need manufacturers that produce materials and components for medical devices, companies that design and manufacture medical devices, and service organizations.

Certification for ISO 13485 certification allows the company to gain access to the markets of other countries, as the requirements of this document are similar to those of many national systems that control medical devices.
The benefits of certification of the company according to ISO 13485
In Ukraine the presence of the certificate ISO 13485 mandatory for all enterprises engaged in production of medical equipment. The application of this standard is an additional guarantee of safety of medical products.
Working to ISO 13485 gives us the following advantages:
  • improving production efficiency;
  • reduced waste and scrap;
  • guaranteed compliance of products with legal requirements;
  • the possibility of entering the international pharmaceutical market.
The validity of the certificate ISO 13485 or three years. After that, the company needs to be re-certified.
Certification from the MNС Group – why clients choose us?
MNС Group is the official representative of the International certification body in Ukraine. We operate for over 10 years and have a reputation of a reliable partner, providing technically sound advice and quality certification services.
Our company provides:
  • Quality technical support;
  • pre-certification audit;
  • certified ISO 13485.
Trust the certification of the enterprise to professionals! Contact our company MNС Group.

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  • Oleksandr Smyrnov, Director of MNC Group
  • Address: Ukraine, Kharkov, Nauki avenue, 60