HTL Strefa

Quality standards

Quality standards

HTL-STREFA products continually fulfill the rigorous international safety and quality standards.

Since its very foundation, HTL-STREFA has maintained and improved a quality management system. The quality management system we have now implemented complies with the EN ISO 13485:2016 standard requirements.

All products are CE marked conforming with 93/42/EEC directive requirements for medical devices in EU. Group of products as pen needle and safety pen needle already are certified in accordance to EU Medical Device Regulation 2017/745.

DEKRA is our certifying entity (

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 US, Canada, China, Mexico, Brazil, Japan and European Union countries.

We hold registrations and marketing authorisations issued by competent authorities and government agencies and certificates of conformity issued by accredited notified bodies allowing us to place the medical devices on the market and put them into service, without limitation:

  • FDA in the Unites States
  • TGA in Australia
  • Anvisa in Brazil
  • HC in Canada
  • MHLW in Japan
  • MFDS in Korea
  • COFEPRIS in Mexico
  • UKRMEDCERT in Ukraine
  • SFDA in Saudi Arabia
  • 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.