Transcription of IVDR Documentation Submissions - BSI Group
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IVDR Documentation Submissions - BSI Group
IVD R Documentation Submissions R ev isio n 3, May 2020 Page 1 of 27 ivdr Documentation Submissions Best Practices Guidelines IVD R Documentation Submissions R ev isio n 3, May 2020 Page 2 of 27 Contents 1 Introduction ..3 2 Submission and Technical Documentation Contents ..3 Cover Letter ..3 The Technical Documentation ..4 authorisation for Work to be Conducted ..4 3 Verificat ion of Performance ..4 Information Required to Support Verification of Manufactured Product (Class D O n ly) 4 4 Submission Method ..5 5 Document Language ..5 Electronic F ile Form at an d File S ize L im it 5 Optical Character Recognition (Searchable Format) .. 7 7 P ag in at io 7 Signatures .. 7 6 S u b miss io n Pro 7 Additional Topics to Consider When Preparing Technical Documentation for S u b miss io n .. 10 Manufacturer Personnel Support .. 10 Document Availab ility .. 10 10 Certificate Scope.
Regulatory Guidanc e Organisations.....25 B3. Specific Topic Guidance .....25 . IVDR Documentatoi n Submsisoi ns – Revision 3, May 2020 Page 3 of 27 ... 2.1 Authorisation for Work to be Conducted A signed approved quote will be required before work can commence. If this is not already in place,
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