HS Design possesses ISO 13485 and ISO 9001:2008 certification from the International Organization for Standardization (ISO). These internationally-recognized certifications are used by service and manufacturing organizations to create a standardized Quality Management System (QMS), which is continuously evaluated to ensure that it conforms to the principles of quality improvement and customer satisfaction.
At HS Design, we are constantly improving the value and integrity of our products and services, with an unparalleled commitment to quality. Our ISO certifications align our management system to the FDA's Quality System Regulation requirements, while meeting the globally recognized ISO requirements for the design and development of medical products.
As the world's largest developer and publisher of International Standards, the ISO is a network of members from 163 countries, with a Central Secretariat in Geneva, Switzerland. ISO is a non-governmental organization that forms a bridge between the public and private sectors, enabling mutual solutions that meet both the requirements of business and the broader needs of society. For more information about ISO, please visit http://www.iso.org