Quality & Standards

Basko Healthcare has named “quality” to one of its basic values and is always working on where the work processes can lead to improvement. The ISO 13485: 2016 of our organisation, and the CE marking of the products, support this view.
ISO 13485:2016
Since October 2017 Basko Healthcare has also received its ISO 13485: 2016 certification. The ISO 13485 standard ensures European harmonization of regulations for the quality of medical devices. A good way to comply with both legislation and product safety and customer requirements. With this standard, we as Basko Healthcare want to impose a number of specific requirements on us as a manufacturer of medical devices. These requirements are about:    
  • registrations relating to customer and legal requirements
  • research and development
  • maintain technical data
  • labeling and packaging
  • product identification and traceability
  • risk management
  • control of specific environmental conditions
  • control of changes during the design, development and production process
CE-Marking European Directives 93/42/EER
The medical products of Basko Healthcare comply with all the requirements of the European Directive 93/42/EER and with legislation regarding medical products. Product developments within Basko Healthcare are tested based on the current requirements and subjected to a conformity assessment before a CE-mark is assigned .
Certificate