Quality & Regulatory Compliance
A number of authorities contribute to ensure that medical devices are safe and well-functioning. It is important that Huntleigh complies with the rules that apply in the markets where our products are sold. Read more about some of the most important authorities and regulations that Huntleigh is subject to below.
The global quality and regulatory compliance certificates that Huntleigh holds can be found at the bottom of the page.
Quality & Regulatory Compliance function
Huntleigh has a Group-wide Quality & Regulatory Compliance function and we have set up a number of product quality and efficiency parameters to ensure high quality. We continuously work to improve internal processes and procedures to ensure compliance and retain a high class quality management system. Our quality management system is certified in accordance with the internationally recognized ISO 9001:2015 and ISO 13485:2016 standards.
Internal auditing – We conduct internal audits at all production units to identify any areas of improvement and to ensure that we comply with applicable requirements and regulation.
View Quality and Environmental PolicyMDSAP Certification
Huntleigh is certified according to the Medical Device Single Audit Program (MDSAP). The MDSAP is based on the global harmonized requirements for medical devices described in the ISO 13485 standard, combined with regulatory requirements from the five member countries, the US, Canada, Australia, Japan and Brazil. This certification means that Huntleigh meets the requirements on these markets. The audit results from the MDSAP are shared with authorities in these five countries and thus replace individual routine inspections.
View MDS Certification
Huntleigh’s Certification
Huntleigh is a leading global provider of innovative and high quality medical equipment for healthcare professionals. Huntleigh can proudly boast world-leading brands such as Dopplex, Hydroven, Sonicaid and Smartsigns, covering healthcare requirements in Vascular Assessment & Treatment, Obstetrics and Patient Monitoring.
Our quality statements can be viewed below
US Food and Drug Administration (FDA)
The FDA requires that Huntleigh complies with the quality system regulation for medical devices in the US.
Health Canada Medical Device Regulation
Health Canada regulates products in accordance with the Canadian food and drugs legislation, which also covers medical devices. This is achieved by evaluating medical devices to assess their safety, effectiveness and quality before being approved for sale in Canada. Health Canada requires that Huntleigh is MDSAP-certified to be able to sell medical devices on the Canadian market
EU Medical Device Regulation (MDR)
Affecting everyone that conducts business within the medical device industry in the EU, the new MDR regulation comes into effect May 2021, with a grace period until the expiry of current CE certificates. As early as 2017, Huntleigh has mobilised a cross-functional task force and worked closely with our notified body to ensure we meet the requirements of the new EU-MDR.
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