Coloplast products improve the lives of people with intimate health care needs around the world.

Listening and responding to the needs of our customers is what drives our work. The feedback that we get from end users is used in as input to the development and testing of new products and new services. One thing we are almost always told is that the quality of our products must always be consistently high.

High standards

Our products are subject to tough quality requirements that follow key international legislation and standards. Coloplast is ISO 9001/ISO 13485 certified and we comply with legislation from the US FDA, the EU and other relevant authorities.

Target Product Profiles

Coloplast develops Target Product Profiles for all our innovation projects. The Target Product Profile provides us with a clear indication of which customer needs we should work to improve. The document is based on extensive data collection methods such as user interviews, focus group sessions, outcome-driven innovation studies, ethnographic and anthropological studies."

Clinical studies

New Coloplast products are evaluated thoroughly before being sent to the market. First, they are tested in the laboratory, including the use of computer models and cell research. If results are promising, the product might then be evaluated on humans in clinical studies.

Coloplast clinical studies are carefully planned to make sure that participants are protected and that the research yields valid results. The protocol – a detailed plan for the study – is reviewed and approved by an independent ethics committee before studies can go ahead. As outlined in our publication policy, our clinical studies are conducted in accordance with internationally accepted ethical and scientific quality standards such as the Ethical Principles for Medical Research Involving Human Subjects.

We publish the results for summary results of all registered clinical studies for marketed products on www.clinicaltrials.gov within 12 months of study completion.

Quality control

Coloplast has an advanced set-up to control that our products of consistently high quality. Staff responsible for quality is involved in the development of new products and in improvements of existing products.

We systematically collect information about quality issues and feed this into our development and research processes. Our quality control furthermore extends to our supply chain, where a team of specialists monitors the quality of raw materials and contract production.

Safe use of our products

Coloplast is committed to informing users about the safe handling of our products. In our product information and on our website, we describe how Coloplast products should be used and how they can best help improve quality of life. We also illustrate the changes in life that often accompanies the start of using Coloplast products, and instruct users in the safe disposal of them.

Sponsorships and donations

In some cases, Coloplast provides financial support for patient organisations within our fields of expertise. We also support sport events, such as our sponsorship of rugby teams for wheelchair users.