Meeting the Demanding Process Control Needs of the Medical Industry

The demanding standards of the medical industry call for a proven provider. Conrad Kacsik helps clients meet the most stringent medical component regulations, including:

  • Code of Federal Regulations (CFR) Title 21, which requires medical device manufacturers, drug makers and a variety of FDA-regulated industries to implement and properly document a set of internal controls on a regular basis
  • FDA Quality System (QS) Regulations, which require manufacturers who commercially distribute medical devices to put quality-management systems in place that guarantee all products meet applicable requirements and specifications

Conrad Kacsik offers the consulting expertise necessary to meet any Nadcap audit criteria, and NIST traceable calibration services that suit any process control need in the medical component industry. We are ISO/IEC 17025:2005 accredited by A2LA (American Association for Laboratory Accreditation).

Providing Superior Quality and Service for 40 Years.

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