The Sorenson Medical Regulatory Affairs(RA) and Quality Assurance (QA) department is staffed with experienced professionals which utilize world class techniques and equipment to continually improve our products and processes.
The QA group focuses on meeting the needs of our customers in the international marketplace. We apply the quality principles of the FDA's QSR and ISO 13485 to the development, manufacturing, and post market surveillance of products. Furthermore, this assures we provide a cost effective product that is safe and effective for our customers.
The RA group is experienced in product requirements and product approvals with the FDA and international marketplace. We continually research the evolving product approval programs and interact directly with government agencies to understand the requirements of each country. We utilize these programs, such as the FDA special 510(k) program to provide our customers with rapid access to our products. Our products are CE marked for distribution in the European Union and affiliated countries of the European economic area. The Annex II certification of our quality system allows us to self certify our products for this growing marketplace. In addition to the US and Europe, we are experienced in product approvals for China, Japan, Canada, Korea, Australia and Latin America.
