Selected PLM-related regulations
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File downloads on this page are provided as a convenient starting point, but may not reflect the most recent regulatory requirements. You are solely responsible for ensuring that you are following the current regulatory requirements affecting your organization.
Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) Download now
* Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste electrical and electronic equipment (WEEE) Download now
UN Economic and Social Council: UN/ECE Recommendation 20:Codes for units of measure used in international trade (15 Jan 2001) Download now
* US Food & Drug Administration: 21 CFR Part 11 "Electronic Records; Electronic Signatures" Download now
US Food & Drug Administration: Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application Download now
US Food & Drug Administration: 21 CFR Parts 808, 812, and 820 "Medical Devices; Current Good Manufacturing Practice (CGMP); Final Rule". Federal Register, Vol. 61, No. 195, 7 October 1996. Download now
* US Food & Drug Administration: 21 CFR Part 820 "Quality System Regulation", 1 April 2003. Download now Also available on-line
US Food & Drug Administration: Design Control Guidance For Medical Device Manufacturers, 11 March 1997. Download now
US Food & Drug Administration: Quality Systems Manual. "Section 9: Document and Change Control" specifically addresses document management.
* Top 3 most popular regulatory and government standards downloads