Transcription of MDR Documentation Submissions - BSI Group
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MDR Documentation Submissions - BSI Group
MDR Documentation Submissions Revision 2, May 2020 Page 1 of 41 ` MDR Documentation Submissions Best Practices Guidelines MDR Documentation Submissions Revision 2, May 2020 Page 2 of 41 Contents 1 Introduction .. 3 2 Submission and Technical Documentation contents .. 3 Cover letter .. 3 The Technical Documentation .. 4 2. 3 Authorisation for the work to be conducted .. 4 3 Submission Method .. 4 4 document Format .. 5 Language .. 5 electronic File Format .. 5 Format and file size limits .. 5 Optical Character Recognition (searchable format) .. 6 Bookmarks .. 6 Signatures .. 7 5 Submission process.
discuss alternate methods of document submission. Please note that documents submitted via any alternate methods will need to be uploaded to our electronic document management system by our administration team, which may add time and cost to the review. • We do not accept hard copies of Technical Documentation.
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