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Establishes requirements for consistent regulatory document appearance and supports harmonized medical device regulatory practices globally. Covers document format specifications including word processing software, paper size considerations, margins, fonts and heading numbering, line spacing, and document element structure. Includes instructions for installing and using the template, configuring headers/footers, and creating a table of contents.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/imdrf-document-format-style-guide-guidance-for-document-developers/170261/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/imdrf-document-format-style-guide-guidance-for-document-developers/170261.png","ImageObject",442,249,{"name":88,"@type":89},"Ivy","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-24","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",13,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What is the purpose of the IMDRF Document Format & Style Guide?","Question",{"text":109,"@type":110},"It provides guidance to those developing and issuing IMDRF documents and explains how to use the accompanying Microsoft Word IMDRF Document Template to ensure a common, consistent appearance.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"Which software should be used to create IMDRF documents?",{"text":114,"@type":110},"Microsoft Word is specified as the word-processing software for the template. Documents not created using the template will be converted by the IMDRF Secretariat prior to posting.",{"name":116,"@type":107,"acceptedAnswer":117},"What are the key formatting requirements for IMDRF documents?",{"text":118,"@type":110},"The guide specifies paper size considerations, margin rules (including a 2.0 cm top margin), Times New Roman font at set pitches, bold numbered headings, and single spacing with defined spacing around headings and sections.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},170261,1788269531,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":20,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":126,"read_time":47},549758252649,"https://ap-avatar.wpscdn.com/avatar/8000253669c5317157?_k=1778319167496531819","Final Document\nTitle:\tIMDRF Document Format & Style Guide\nAuthoring Group:\tIMDRF Management Committee\nEndorsed by:  IMDRF Management Committee\nDate: \t7 March 2014\nJeffrey Shuren, IMDRF Chair\nThis document was produced by the International Medical Device Regulators Forum. There are no restrictions on the reproduction or use of this document; however, incorporation of this document, in part or in whole, into another document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the International Medical Device Regulators Forum.\nCopyright © 2014 by the International Medical Device Regulators Forum.\nCONTENTS\n\u0013 TOC \\o \"1-3\" \u00141.0\tIntroduction\t\u0013 PAGEREF _Toc488157766 \\h \u00144\u0015\n2.0\tScope\t\u0013 PAGEREF _Toc488157767 \\h \u00144\u0015\n3.0\tReferences\t\u0013 PAGEREF _Toc488157768 \\h \u00144\u0015\n4.0\tDefinitions\t\u0013 PAGEREF _Toc488157769 \\h \u00144\u0015\n5.0\tDocument Format\t\u0013 PAGEREF _Toc488157770 \\h \u00144\u0015\n5.1\tWord Processing Software\t\u0013 PAGEREF _Toc488157771 \\h \u00145\u0015\n5.2\tPaper Size\t\u0013 PAGEREF _Toc488157772 \\h \u00145\u0015\n5.3\tMargins\t\u0013 PAGEREF _Toc488157773 \\h \u00145\u0015\n5.4\tFont\t\u0013 PAGEREF _Toc488157774 \\h \u00145\u0015\n5.5\tLine Spacing\t\u0013 PAGEREF _Toc488157775 \\h \u00145\u0015\n5.6\tPage Numbering\t\u0013 PAGEREF _Toc488157776 \\h \u00146\u0015\n6.0\tDocument Elements\t\u0013 PAGEREF _Toc488157777 \\h \u00146\u0015\n6.1\tTable of Contents\t\u0013 PAGEREF _Toc488157778 \\h \u00146\u0015\n6.2\tPreface\t\u0013 PAGEREF _Toc488157779 \\h \u00146\u0015\n6.3\tCover Page\t\u0013 PAGEREF _Toc488157780 \\h \u00147\u0015\n6.4\tIntroduction\t\u0013 PAGEREF _Toc488157781 \\h \u00147\u0015\n6.5\tScope\t\u0013 PAGEREF _Toc488157782 \\h \u00147\u0015\n6.6\tReferences\t\u0013 PAGEREF _Toc488157783 \\h \u00148\u0015\n6.7\tDefinitions\t\u0013 PAGEREF _Toc488157784 \\h \u00148\u0015\n6.8\tDocument Body\t\u0013 PAGEREF _Toc488157785 \\h \u00148\u0015\n6.9\tExamples\t\u0013 PAGEREF _Toc488157786 \\h \u00149\u0015\n6.10\tAppendices\t\u0013 PAGEREF _Toc488157787 \\h \u00149\u0015\n7.0\tInstalling the IMDRF Document Template\t\u0013 PAGEREF _Toc488157788 \\h \u00149\u0015\n8.0\tUsing the IMDRF Document Template\t\u0013 PAGEREF _Toc488157789 \\h \u001410\u0015\n8.1\tOpening the Document Template\t\u0013 PAGEREF _Toc488157790 \\h \u001410\u0015\n8.2\tFilling in the Template\t\u0013 PAGEREF _Toc488157791 \\h \u001410\u0015\n8.3\tUsing the Template Header\t\u0013 PAGEREF _Toc488157792 \\h \u001410\u0015\n8.4\tUsing the Template Footer\t\u0013 PAGEREF _Toc488157793 \\h \u001411\u0015\n8.5\tCreating a Table of Contents\t\u0013 PAGEREF _Toc488157794 \\h \u001412\u0015\n\u0015\n\u000fPreface\nThe document herein was produced by the International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulators from around the world.\nThere are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the International Medical Device Regulators Forum.\u000f1.0 Introduction\nThe purpose of this document is to act as guidance to all those involved in developing and issuing International Medical Device Regulators Forum (IMDRF) documents and it is designed to be used with the accompanying Microsoft Word IMDRF Document Template.  By using the IMDRF Document Template, members involved in developing new documents will be using a prescribed format, resulting in each new IMDRF document having a common and consistent appearance.  This in turn, will contribute to their important use in achieving harmonized regulatory practices for medical devices around the world.\nComments or questions about the use of the Document Template or this guidance document should be directed to the IMDRF Secretariat.\n2.0 Scope\nAll persons involved in or responsible for the creation or issuance of IMDRF documents are encouraged to read this document and to use the accompanying IMDRF Document Template.\nThe IMDRF document template was created, and should be used, in the application Microsoft Word.\n3.0 References\nThroughout this document, references are made to the IMDRF document entitled “Operating Procedures”.\n4.0 Definitions\nTemplate:\tthe file ‘IMDRF document template.dot’\nField:\t\ta pre-formatted area of the template where specific text can be entered.\nClick:\t\tone mouse c","cbCaityPGoDQ6GV5","https://ap.wps.com/l/cbCaityPGoDQ6GV5","docx",80803,"English","# Introduction\n# Scope\n# References\n# Definitions\n# Document Format\n## Word Processing Software\n## Paper Size\n## Margins\n## Font\n## Line Spacing\n## Page Numbering\n# Document Elements\n## Table of Contents\n## Preface\n## Cover Page\n## Document Body\n## Examples\n# Installing the IMDRF Document Template\n# Using the IMDRF Document Template\n## Filling in the Template\n## Using the Template Header\n## Using the Template Footer\n## Creating a Table of Contents","[{\"question\":\"What is the purpose of the IMDRF Document Format \\u0026 Style Guide?\",\"answer\":\"It provides guidance to those developing and issuing IMDRF documents and explains how to use the accompanying Microsoft Word IMDRF Document Template to ensure a common, consistent appearance.\"},{\"question\":\"Which software should be used to create IMDRF documents?\",\"answer\":\"Microsoft Word is specified as the word-processing software for the template. Documents not created using the template will be converted by the IMDRF Secretariat prior to posting.\"},{\"question\":\"What are the key formatting requirements for IMDRF documents?\",\"answer\":\"The guide specifies paper size considerations, margin rules (including a 2.0 cm top margin), Times New Roman font at set pitches, bold numbered headings, and single spacing with defined spacing around headings and sections.\"}]","IMDRF Document Format & Style Guide - guidance for document developers | DOCX"]