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