Product quality
It is essential to Coloplast’s mission to deliver safe and reliable products. That is why Coloplast has a unified global quality management system with established uniform global processes to manage quality and risks throughout product development, production, and distribution as well as extensive postmarket surveillance.
Quality Standards
All customer feedback, complaints and adverse events are handled on an individual basis, identifying the root cause, and generating input for mitigations, product improvements as well as future product development. As part of a regulated industry, Coloplast’s products and quality management system live up to strict regulatory standards established by authorities worldwide such as the FDA, Japanese Ministry of Health, the International Standardization Organization, and the European Commission. Compliance to these standards is verified on site through external audits by independent auditors and Notified Bodies.
If customer feedback or internal controls reveal that already distributed products have quality defects with a potential risk of safety, Coloplast will initiate a voluntary product recall to remove the products from the supply chain as well as the market.
Animal testing
Animal testing is a standard method for documenting the safety of medical devices. By having a precise account of the composition of Coloplast products, animal testing can be avoided. However, in some cases animal testing is necessary due to legal requirements and safety assessments. All animal testing used by Coloplast are performed by Good Laboratory Practice certified laboratories. This year, Coloplast used 1,576 animals for testing in relation to pre-clinical safety documentation. There has been an increase in use of animals for testing compared to last year due to tests for MDR submission on old devices to comply with MDR requirements. Coloplast does not use transgenic animals in testing.