Regulatory and strategic support for successful market entry and market compliance!
We provide services for medical device manufacturers. We support our clients with various services necessary for medical device approval. For example, we offer services such as quality management, risk management, biological evaluation, specialized literature searches, and clinical evaluations. Our company is a strong partner that addresses various scientific and regulatory needs. 【Service Overview (Partial)】 ■ Comprehensive consulting services and strategies for entering international markets ■ Internationally approved quality management systems ■ Addressing the impact of medical devices on human health and the environment ■ Specialized literature search and provision services for clinical evaluations and other needs ■ Qualification confirmation and validation of manufacturing and quality management equipment and methods *For more details, please refer to the PDF document or feel free to contact us.
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basic information
**Benefits** - Extensive knowledge is provided regarding standards and regulations related to quality and approval. - Conduct detailed gap analyses and plan for budget and approval timelines. - Guide you through all processes necessary for medical device approval and prepare required documentation. - Provide guidance on borderline products and offer unique advice on approval strategies. *For more details, please refer to the PDF document or feel free to contact us.*
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For more details, please refer to the PDF document or feel free to contact us.
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Company information
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.