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. 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 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:
HTL-STREFA holds multiple quality certifications:
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.