Mölnlycke Health Care will continuously strive for industry leading reliability and quality in our products and services in the interest of patient safety, customer satisfaction and business excellence. We will comply with all applicable laws and regulations regarding the safety and efficacy of our products and we will comply with the applicable standards for our processes.
Mölnlycke Health Care operates in accordance with the following regulations and standards:
• The European Medical Device Directive 93/42/EEC
• The US Medical Device Quality Systems Regulation (QSR)
• The Quality Management Standards ISO 9001 and ISO 13485
• The Environmental Management Standard ISO 14001
Mölnlycke Health Care holds a Quality System Certificate and several CE certificates. The certificates can be requested by sending an email to: email@example.com (the certificates are available in English only). Find the complete list of certificates here.