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MDR Documentation Submissions - bsigroup.com

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.

MDR Documentation Submissions – Revision 1, September 2018 Page 1 of 29 ` MDR Documentation Submissions . Best Practices Guidelines

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