Biomedical Certification Standards an International Review


Rosen, Heinz   (1987, ASQC)   Underwriters Laboratories, Melville, NY

41st Annual Quality Congress, May 1987, Minneapolis, MN    Vol. 41    No. 0
QICID: 3291    May 1987    pp. 165-168
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Article Abstract

Exporting products to foreign markets generally requires that the products comply with applicable standards. Frequently, third-party certification attesting to that compliance is also a prerequisite before products are permitted to be distributed. The difficulty for the export-oriented manufacturer is two-fold, (1) the identification of the various relevant requirements which, if they are contradictory, may necessitate the production and stocking of multiple models and (2) the unravelling and negotiation of the certification process itself. The purpose of this paper is to clarify some of these issues.



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