HTL Strefa

Quality standards

Quality standards

HTL-STREFA products consistently exceed the most rigorous international safety and quality standards.

Since inception, HTL-STREFA has maintained and improved the quality management system. The currently implemented quality management system is compliant with the requirements of EN ISO 13485: 2016. All products are CE marked conforming with 93/42/EEC directive requirements for medical devices. DEKRA is our certifying entity (http://www.dekra-certification.com).

Since January 2019, HTL-STREFA holds Medical Device Single Audit Program Certificate (MDSAP), confirming compliance with ISO 13485:2016, and the regulatory requirements of five different jurisdictions: Australia, Brazil, Canada, Japan and the United States.

HTL-STREFA products are sold in over 80 countries – including restrictive markets like Brazil, US, Canada, China and Japan.

We have received full approval/authorization from:

  • FDA in the Unites States
  • TGA in Australia
  • Anvisa in Brazil
  • HC in Canasa
  • MHLW in Japan
  • MFDS in Korea
  • COFEPRIS in Mexico
  • UKRMEDCERT in Ukraine
  • DEKRA Certification B.V. in the European Union

HTL-STREFA holds multiple quality certifications:

Manufacturing control:

HTL-STREFA operates two fully automated, vertically integrated manufacturing facilities in Poland. We maintain complete control over quality and design for all aspects of each product. Our team of dedicated engineers provides constant quality improvements to our products and processes, while also developing new and innovative solutions.