Our Quality Standards
Fetzer Medical Takes Responsibility!
Each of our employees assumes a piece of responsibility for the products that are to help people. We are aware of this responsibility and reflect it in all areas of our company through the high quality awareness of our individual employees. The safety of our products is our top priority – for this reason our company is based on a well-founded and continuously developing Quality Management System. The company’s management is committed to a continuous improvement of the effectiveness of the QM system and to create necessary conditions for the implementation of our goals.
Quality With a Seal
Through our certified QM system according to DIN EN ISO 13485:2016 as well as compliance with the requirements according to 21 CFR 820 Quality Systems Regulation, we ensure an ever-increasing quality of our products and services. However, constants in the system are also indispensable for increases: through detailed product specifications, systematically planned product tests and validated processes, we ensure a solid basis for performance improvements. Our processes and most important key performance indicators are monitored on a regular basis.
Supply Chain Management
Our own manufacturing processes are subject to strict regulations and controlled change management. If required, we provide you with all relevant manufacturing information.
All our suppliers undergo a qualification phase tailored to their performance before they are approved for delivery of goods or services. An early involvement of our suppliers in new projects ensures a high and consistent quality along the supply chain.
All relevant information for complete process traceability is kept by us and stored in accordance with legal requirements. We will be happy to work with you to develop specifications and with the support of our know-how, assemble information for your technical documentation.
Our customers are faced with growing challenges regarding regulations of medical devices and compliance with legal and regulatory requirements around the world. Globally, documentation requirements are increasing with respect to fundamental issues such as Medical Device Safety, Performance Requirements and Supply Chain Management. Fetzer Medical is aware of these requirements and is always familiar with current changes. We offer support in all relevant areas and, if required, we provide comprehensive documentation to support you in your legally required obligations.