QM system
In order to achieve consistent quality, botiss biomaterials GmbH maintains a Quality Management System in accordance with DIN EN ISO 13485 (including the Taiwanese GMP via the Technical Cooperation Programme), Council Directive 93/42/EEC, the German MPG, QS requirements of the MDSAP (medical device single audit program) member countries Australia (Therapeutic Goods (Medical devices) Regulations 2002), Brazil (Brazilian Good Manufacturing Practices RDC 16/2013, RDC 23/2012 und 67/2009), Japan (Ministerial Ordinance No.169 (Japanese Medical Device QMS Requirements and other related Regulatory Information), Canada (Medical Devices Regulations (SOR/ 98-282)) and USA (21 CFR 803 Medical Device Reporting, 21 CFR 806 – Medical Devices; Reports of Corrections and Removals, 21 CFR 807 – Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices, 21 CFR 820 – Quality System Regulation, 21 CFR 821 – Medical Device Tracking Requirements).
As part of this QM system, all actions necessary to achieve our quality standards are defined and implemented, taking the valid statutory regulations into account.