Medical

Meeting the Demanding Process Control Needs of the Medical Industry

The demanding standards of the medical industry require a proven provider. Conrad Kacsik helps clients meet the most stringent medical component regulations. With extensive knowledge of special processes, Conrad Kacsik can help ensure you will meet any standard required in the medical industry.

We help medical device manufacturers achieve accreditation and adhere to requirements for many different medical manufacturing industry standards, including:

MedAccred

MedAccred is administered by the Performance Review Institute (PRI). MedAccred covers critical processes in medical device manufacturing. Developed in 2012, it is the gold standard for supply chain management in the medical industry.

Adhering to MedAccred and meeting audit standards is challenging, but Conrad Kacsik has the team and experience to help ensure your success. Conrad Kacsik is deeply familiar with the PRI and its requirements and even has employees who provide training for PRI. Additionally, most of the process control and pyrometry requirements of MedAccred are similar to Nadcap, which the PRI also administers.

Conrad Kacsik is one of the foremost experts in Nadcap and has been helping customers meet MedAccred standards since its inception.

Code of Federal Regulations (CFR) Title 21

This regulation 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

This requires manufacturers that commercially distribute medical devices to put quality-management systems in place that guarantee all products meet applicable requirements and specifications.

Additionally, 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 manufacturing 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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