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Development and implementation of DSTU ISO

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Availability of quality management system (QMS) is a requirement for domestic and foreign manufacturers for the following classes of medical devices:

  • Medical Products Is (sterile), I with measuring function, IIa, IIb, III classes, according to the Technical Regulations on medical devices;
  • The reagents, calibrators and controls, which entered the list of "A" and "B" Technical Regulation of medical devices for the diagnosis of in-vitro, products for self-control;
  • All medical devices that fall under the Technical Regulations of active implantable medical devices.

The specialized national standard for manufacturers of medical products is DSTU ISO 13485:2005. QMS must be developed and implemented; system certification is not a requirement of the Technical Regulations and is performed at the request of the manufacturer. For domestic manufacturers, who plan to export their products to EU markets it is necessary to have the international standard ISO 13485.

Often, the company already has a quality management system, and it requires the analysis and refinement to meet the requirements of standard DSTU ISO 13485.

We offer services:

  • Diagnosis and analysis of the quality management system in the enterprise
  • Development of documentation: quality manual, standard operating procedures (SOP), instructions, procedures, policies, and so on.
  • Training for staff, namely:
    • Internal audit of the QMS. Standard ISO 19011;
    • Fundamentals of quality management. Standard ISO 13485;
    • Directives 93/42/ЕЕС, 98/79/EEC, of the Technical Regulations of Ukraine;
    • Risk management for medical devices, standard ISO 14971;
  • Implementation of the quality management system;
  • Pre-certification audit. 

The cost of developing and implementing QMS depends on several factors:

  • The number of personnel in the enterprise;
  • The presence of regulatory documentation in the enterprise (SOPs, orders for admission of employees, job descriptions, registers with the evaluation of suppliers, work instructions (safety, electrical safety, fire safety, etc.), etc .;
  • Availability of the other QMS (ISO 9001, Good Manufacturing Practice - GMP and others);
  • List of products, production lines;
  • Types of production operations, running in production.