Medical Products


Medical equipment is becoming more important all the time in the healthcare industry, and worldwide regulatory and certification processes are of great interest and importance. The need for harmonization of legislation, especially between European Union countries and worldwide, is very important.

Medical Products

These regulations and international standards take into account all steps of medical products from design to production stages and process verification. All these activities are necessary for the product certification process.

The world of medicinal products includes an incredibly wide range of products. This leads to the complexity of the certification process and the fact that all possible product and stakeholder categories in the healthcare industry must be considered.

There are two very important guidelines for companies producing medical equipment:

  • TS EN ISO 9001 Quality management systems - Requirements
  • TS EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes

Basically, QLabel quality certification is based on these two standards and is made for medical products that have been tested during the design and production processes and have been proven not to be harmful to human health and the environment.

In general, the main products for which QLabel quality certification is carried out within the scope of medical products are, but are not limited to:

  • Sphygmomanometers
  • Respiratory equipment
  • air beds
  • wheelchairs
  • Diapers
  • orthopedic products
  • diabetes shoes
  • patient bed
  • thermometers
  • Oxygen cylinders
  • Hearing aids
  • syringes
  • Maskeler
  • surgical gowns
  • disinfectants

Based on years of experience and knowledge, our organization provides testing, analysis, measurement and evaluation services as well as numerous certification services. In these studies, it draws its strength from its experienced staff and advanced technological facilities, and is based on current legal regulations and standards developed by domestic and foreign organizations. In this context, it also provides QLabel quality certification services for medical products to requesting individuals and organizations.