Quality

Quality Control – The backbone of BDK

BDK’s robust quality management system has enabled us to earn a reputation for outstanding quality.

BDK is committed to providing excellent quality and service. We have been accredited to ISO 9001 since 1991 and hold ISO 13485 accreditation for the production of medical devices.

BDK operates a class 7 (class 10,000) clean room manufacturing facility compliant with BS EN ISO 14644 which allows us to manufacture products for the medical and electronics industries. This facility is bio-burden controlled and monitored.


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  • ISO 9001 Accredited

  • ISO 13485 Accredited

  • Full batch traceability

  • Full capacity studies & process validation (IQ,OQ,PQ)

  • Range of specialist test equipment

  • On-line inspection and measuring systems

  • Environmental test chamber

  • SPC (statistical process control) & CPK studies

  • FMEA (fail mode & effort analysis

  • FDA registered facility


View ISO 9001 Certificate

View ISO 13485 Certificate