New medical devices are evaluated thoroughly before being used by patients.

Medical devices are first tested in the laboratory; by including the use of computer models, cells and animal research. If the results are promising the medical device might then be evaluated in humans, in clinical studies.

Clinical studies are carefully planned to make sure that participants are protected and that the research yields valid results. A detailed plan for a clinical study, known as a "protocol", is prepared by the company and reviewed and approved by an independent ethics committee before studies can go ahead.

All Coloplast A/S (including subsidiary and related companies) sponsored clinical studies are conducted according to the relevant guidelines.

These guidelines provide an internationally accepted ethical and scientific quality standard for designing, conducting, recording, reporting, and publishing studies. Clinical evidence from studies or literature research is compulsory for all new devices. Regulators will only give approval for a new medical device if the evidence demonstrate a favorable benefit: risk profile.

Our main concern is the safety and well-being of the people using our products. To make it possible for both users and healthcare professionals to make informed decisions, we communicate information on our products accurately and objectively. Our policies on ethical behavior and social responsibility are guided by our membership of the United Nations Global Compact.

Download our policy for scientific, technical and medical publications