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.
Documentation but is difficult to locate. To reduce the frequency of the above issues, BSI Medical Devices group proposes the following guidelines, informally known as “MDR Documentation Submissions: Best Practices Guidelines”. 2 Submission and Technical Documentation contents Three things are required for any Technical Documentation review:
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