EN ISO Certificates
Our quality management system, certified in accordance with EN ISO 13485: 2016, comprises detailed organisational regulations and testing instructions that ensure we are always compliant with the highest standards of quality. Sporlastic products bear the CE mark, documenting that they satisfy the fundamental requirements of medical products legislation.
SME Global - Health made in Germany
The Federal Ministry for Business and Energy (BMWi) is strengthening its support for the German health economy through the Health Economy Export Initiative. The aim is to boost and expand Germany’s position as one of the leading export countries of health products and services.
Declaration of conformity according to regulation (EU) 2017/745
SPORLASTIC, as manufacturer and distributor of medical devices of risk class 1, is responsible for demonstrating compliance with the essential requirements by means of the conformity assessment procedure and documenting this by means of the declaration of conformity and the CE mark. Our medical devices meet the essential requirements of the European regulation (EU) 2017/745.