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Production sites

 

We produce innovative regenerative biomaterials derived from collagen, allografts, xenografts and synthetic materials for a wide range of dental surgical applications.

 

Thus botiss can guarantee to offer outstanding biological reliability and performance for a successful and predictable treatment outcome.

 

Our production sites are located in Krems (AT), Sheffield (UK), Dieburg (DE) and Neustadt-Glewe (DE). Here botiss performs quality control audits regularly.

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 maintains a QM system in accordance with EN ISO 13485, Council Directive 93/42/EEC concerning Medical Devices, ISO 13485 (CMDCAS [Canadian Medical Devices Conformity Assessment System] and TCP [Taiwan Technical Cooperation Program]), the CMDR (Canadian Medical Device Regulation) and the PAA (Pharmaceutical Affairs Act). 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.

 

Of course our whole QM/RA department observes all the time updates and innovations regarding the standards and is thus always well informed and operates accordingly.