Quality Assurance

Quality assurance (QA) is an integral part of our business system and production process. It supports the full spectrum of our services. Being one of the leading companies in medical contract manufacturing, our Quality Management System (QMS) has been crafted so that we can provide total customer satisfaction as well as the highest quality products. The quality control teams at our production facility are dedicated to ensuring that our efficiency is on par with the highest industry standards. We use non-hazardous materials certified by all types of safety standards while only using feedstock that is consistent with these standards. This commitment to quality has been our key for establishing long-term contracts with our customers and will be the key to developing new relationships in the future.

Regulatory Compliance and Consulting

Our manufacturing facilities are compliant with the requirements of the FDA’s Quality System Regulation (QSR) and Current Good Manufacturing Practice (CGMP), and our QMS is certified to the international standards ISO9001:2000 and ISO13485:2003

Our product development and manufacturing processes are regularly audited under the direction of internal auditing team as part of our ongoing commitment to continuous quality improvement. Additionally, SGS also audits our quality system and facilities on a regular basis for maintenance of this registration. You can count on our quality with confidence. Our quality procedures assure our clients that our services meet their standards of excellence for medical product design, development, and manufacturing controls. For companies seeking entry to the European market, we are also qualified to provide the technical product documentation needed to meet CE requirements.

We also have solid experience in application of various kinds of regulatory licenses according to the required compliance system of the respective health authorities around the world.