Process-oriented Quality Assurance
The quality management system of em-tec GmbH, the manufacturer of the equipment, is certified to ISO 13485 and fulfills FDA 21 CFR Part 820 (Quality System Regulation QSR (USA)), which ensures also conformity with U.S. cGMP. The QM system provides for a correct, complete documentation of the project and ensures that all the strict guidelines are observed throughout the development process. Customers are thus well prepared for approval. We have experience with many classes of CE and FDA approvals.