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TITERTEK-BERTHOLD

Titertek-Berthold, based in Pforzheim, Germany, spezializes in the development, manufacture and distribution of high performance bench-top instruments for the Life Science laboratory. We provide high-quality German engineering, reliable and easy-to-use products for academic, biotech and diagnostic applications.

Titertek-Berthold products and services are available all over the globe. In addition to expert advice from the German headquarters, you can expect reliable sales and after-sales support from our network of certified partners worldwide. 

 

 

Quality management is a top priority in the company: We have been ISO 9001 certified since 1998 and the company has earned ISO 13485 certification in 2009, qualifying it as a dependable supplier to medical diagnostics markets.

Our history:
Titertek was founded in Huntsville, Alabama in March 1996 and became famous for precision, microliter-range liquid handling products. 
Berthold Detection Systems, also founded 1996, established the most complete range of luminometers.

DIN EN ISO 13485 and 9001 Certificates

Berthold Detection Systems' quality management is certified ISO 13485 and 9001. This achievement underlines our strong commitment to quality in serving customers in the diagnostic and life science markets.

By meeting customer demands at a consistently high level, we assure high quality and compliance with all applicable directives, regulations and standards.

The scope of our certification covers the development, production and distribution of sample-handling and measurement instruments for the life sciences, including in-vitro diagnostics.

CAN/CSA ISO 13485 Certificate

In August 2014 our company was awarded the CAN/CSA ISO 13485 certificate by TÜV Nord, a Health Canada recognized registrar. Compliance with the Canadian Medical Device Regulations enables us to licence and market our IVD devices in Canada.

Quality Monitoring

All critical working processes are continuously monitored to document that the specified quality is achieved. A Corrective and Preventive Action System (CAPA) is applied to analyze performance and implement quality improvements.

Quality Audits

Quality audits are carried out to verify that all activities comply with existing quality documentation and that the quality system is efficient and user-friendly. Four types of audits are executed:

  • Internal quality audits of all departments based on a yearly audit plan
  • Audits of customers
  • Audits of suppliers
  • Audits by independent certifying organizations

Jobs

Currently we have no open vacancies.