Quality & Regulatory View Regulatory Classification Information Providing medical devices which are able to assist clinicians and caregivers to improve patient care and outcomes is fundamental to our success. Our products are used in the treatment of millions of people around the world each year. We are continuously improving our products and the way in which they are manufactured so that we achieve the levels of quality and reliability that our patients and caregivers expect. With the healthcare device industry regulated worldwide, the ability to meet stringent standards is vital to ensuring market acceptance of our products. We assist our compliance with these standards by operating a quality management system certified to international standards which apply to both our manufacturing facilities and our sales network. As manufacturers of medical devices we are required to comply with a wide range of country specific regulations and are routinely audited for compliance to the applicable regulations. Our products destined for the United States must comply with the US Food and Drug Administration Quality System Regulation and require market clearance prior to commercialisation. Similarly, our products destined for the EU, Canada or Japan must comply with the ISO 13485 Quality Management System standard, as well as country-specific regulations. Underwriters Laboratories also carry out safety tests on our products and certify our products’ compliance with relevant product safety standards. We are continually improving our quality management system to ensure that our processes and procedures meet both our business needs and changing international regulatory requirements. Continuous improvement ensures that the quality of our products and services meets the expectations of our patients and customers. Quality Certificates ISO 13485 Certificate - Mexico ISO 13485 Certificate - New Zealand ISO 27001 Certificate - Informatics MDSAP Certificate - Canada, U.S, Japan, Brazil & Australia EC Certificate HDS:2018 - New Zealand Informatics (English) HDS:2018 - New Zealand Informatics (French) Quality Manuals Supplier Quality Manual About Us All of F&P Search US Login History Directors Executive Management Quality & Regulatory THERAPIES Adult Respiratory Infant Respiratory Sleep Apnea Home Nasal High Flow Home Humidification COVID-19 Resource Center PRODUCTS All Hospital Products All Homecare Products SERVICES F&P Education OUR COMPANY About Us Careers Investor BluePrints Sustainability Newsroom © 2021 Fisher & Paykel Healthcare Limited. Global Privacy Statement Terms of Use Recruitment Fraud Contact United States