Improvements in Processing and Manufacturing at CeramTec

  • G. Griesmayr
  • M. Dietrich
  • J. Kasprowitsch
  • H. Dobbs
Conference paper
Part of the Ceramics in Orthopaedics book series (CIO)


As many of you already know, with effect from February 2003 CeramTec together with two of its customers has been successful in obtaining FDA approval for the supply of ceramic inserts to the USA. Such approvals were not easy to obtain. This paper discusses what CeramTec has done to achieve these objectives.


Ceramic Insert Software Validation External Requirement Failure Mode Effect Analysis Final Inspection 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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  1. 1.
    H-G Pfaff, GMP Compliant Quality Management Systems—A Contribution to Product Satety, in: Bioceramics in Joint Arthroplasty (eds JP Garino and G Willmann), pp 34–36, Georg Thieme, Stuttgart, 2002.Google Scholar
  2. 2.
    FDA Quality System Regulation (21 CFR Part 820)Google Scholar
  3. 3.
    FDA Guidance Document on General Principles of Process ValidationGoogle Scholar
  4. 4.
    FDA Guidance Document on General Principles of Software ValidationGoogle Scholar

Copyright information

© Steinkopff Verlag, Darmstadt 2003

Authors and Affiliations

  • G. Griesmayr
  • M. Dietrich
  • J. Kasprowitsch
  • H. Dobbs

There are no affiliations available

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