High Standards /
Medical devices /
Pharmaceutical products /
Pharmaceutical entrepreneur according to Section 4 Subsection 18 of the German Medicines Act (AMG)

WE ARE MANUFACTURER

All products are manufactured under the strictest quality controls, keeping our biomaterials at the highest scientific and quality standards.

The products of the botiss regeneration system have proven their success in terms of safety, efficacy, and reliability in a multitude of preclinical and clinical studies and, most importantly, in the daily clinical work with hundreds of thousands of patients treated worldwide.

According to MDD 93/42/EEC botiss is a legal manufacturer of medical devices. Therefore, we have implemented a quality management system conforming to EN ISO 13485.

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.