Certifications

Our comprehensive quality management system governs all processes successfully from the comments and suggestions of our users.
 

 

We are laced with standard certificates ISO 9001: 2015, ISO 13485-2016, CE Class I, Class IIa Annex V, MDD 93/42/EEC, cGMP approved by FDA (USA).
 

 

From receiving to final inspection, all products are subject to several checks and inspections at BTI. At the time of completion, a 100% check is carried out in addition. Any deviations or deficiencies found are at once corrected.

 

For many years, BTI has been operating a high-tech laboratory where check analyses and examinations are carried out and documented. Where necessary, we also work with well-known institutes as partners. This enables us to put materials and products to the acid test well before they reach the market.
 

 

Our lab staff is in a position to simulate even extreme instrument processing conditions, thanks to testing equipment (sterilizer, washer-disinfector) with special setting options. In addition to such lab work, our application engineers also offer qualified on-site testing, thus helping customers to optimize their processes in their own environments.
 

 

All our quality assurance efforts are rigorously centered on customer expectations, whether products, services or processes are concerned. As a visible token of our commitment to top quality, our products carry the CE-mark.


Download Our Certifications