Services for Medical Device Manufacturers <Quality Control>
Practical support in process optimization, monitoring, and document creation!
Our company ensures compliance with ISO 13485, MDR 2017/745, other QMS standards, and legal requirements in various countries through practical expertise in quality management, providing comprehensive support. Creation and maintenance of the Quality Management Manual (QMM). Formulation of quality policies, including quality plans and quality objectives, and identification of key performance indicators that enable objective process evaluation. [Overview of Quality Management Services] ■ Gap analysis and standards investigation ■ Practical support in process optimization, monitoring, and documentation ■ Guidance on EUDAMED (European Medical Device Database) *For more details, please refer to the PDF materials or feel free to contact us.
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Our company was established in 1989 by Dr. Friedbert Pistel. Currently, we provide support and services to meet the needs of global customers in the fields of pesticides and biochemicals, chemicals/REACH, biocides, cosmetics and consumer products, food packaging, feed and food additives, medical devices, and GLP-compliant data storage facilities.