Quality Management
Our Quality Management System is certified according to DIN EN ISO 13485 and MDSAP (requirements of the regulatory authorities Australia TGA, Brasilia ANVISA, Health Canada, USA FDA, Japan MHLW/PMDA).
The focal point of our Quality Management System is the high quality requirement regarding the performance and safety of our products and the satisfaction of our customers.
Scope of VBM Quality Management System
- ISO 13485:2016
- Medical Device Regulation (EU) 2017/745
- USA: 21 CFR Part 820 – Quality System Regulation
- Canada: Medical Device Regulations
- Brazil: ANVISA – Good Manufacturing Practices
- Australia: Therapeutic Goods Regulations
- Japan: MHLW, PMD Act
- Korea: Good Manufacturing Practices
- Taiwan: Good Manufacturing Practices
- Medical Device Directive 93/42/EEC
Quality Policy
We provide excellent product quality for medical products within the range of Airway Management, Accessories for Anesthesia & Intensive Care and Tourniquets, by adhering to international standards, by fulfilling the requirements for maintaining the effectiveness of the quality management system and by a close collaboration with our customers. Our corporate culture is the basis for motivated and qualified employees. Our quality management system is based on effective processes, which are shared and understood by our staff.
Through sustainable corporate management, we promote long-term health and quality of life and pavethe way for an environmentally friendly future.
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