Usable version of MDR in Word format

Asherlee

Involved - Posts
#1
To all,

I have started preparing a gap analysis for the transition from the MDD to the MDR. I found that the official publication of the MDR (pdf format) is not "easy" to work with, as it has no Table of Contents, and when doing copy and paste from the pdf version of the MDR, the format and/or numbering was often corrupted in the process. I then created a Word version of the MDR, with a TOC at the beginning of the document; in addition, by going to VIEW in Word, and then clicking on the navigation checkbox, you can see the TOC on the left side of the Word document. Remember that the MDR has 123 Articles, and 17 Annexes, so a TOC is crucial for navigating the document.

I am attaching my Word file for the benefit of the Elsmar forum with one request; if you find any mistakes in my Word file (formatting, numbering,content, etc.), please let me know via the discussion thread, so that I can correct them.

Thanks

Asherlee
 

Attachments

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
J Sterilisation Validation of Re-Usable Hospital Instruments ISO 13485:2016 - Medical Device Quality Management Systems 1
M Quantifying "Risk" as a Usable Management Metric Quality Manager and Management Related Issues 3
H Usable Torque Range - Using a torque driver at more than 80% of its range Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
Q How can electronic components be rendered physically "un-usable" when Nonconforming AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 16
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
M When is EN 62133-1 (new version i.e. IEC 62133:2017) mandatory in EU Other ISO and International Standards and European Regulations 0
I Reissuing documents due to missing version / issue numbers Document Control Systems, Procedures, Forms and Templates 3
M Can someone share a scrubbed version of Clinical Evaluation Plan (CEP) EU Medical Device Regulations 1
F Management of Software version while NB reviews Technical file CE Marking (Conformité Européene) / CB Scheme 7
M Harmonised RED Standard ETSI EN 440 - Which Version? Other ISO and International Standards and European Regulations 0
M Informational EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 and related documents Medical Device and FDA Regulations and Standards News 2
M Informational EU – MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.22 (05-2019) Medical Device and FDA Regulations and Standards News 2
dgrainger Informational Updated Borderlines manual - Version 1.22 (05-2019) EU Medical Device Regulations 0
dgrainger MHRA guidance on Virtual manufacturing - version 2 EU Medical Device Regulations 1
M Scrubbed version of a labeling procedure that is MDR compliant wanted EU Medical Device Regulations 3
B QRQC vs JIDOKA - I read somewhere that QRQC is like a French version of JIDOKA Problem Solving, Root Cause Fault and Failure Analysis 2
C Has an amended version of IEC 60601-1-6 TRF been released for use in conjunction with IEC62366-1:2015? Human Factors and Ergonomics in Engineering 0
Sidney Vianna Accessing the Xenforo version of Elsmar via a smartphone Elsmar Xenforo Forum Software Instructions and Help 8
A AS9100 Rev:D in Spanish - where can I find a Spanish version? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
D I heard that there is no new version of ISO 18001 OHSAS after 2017 version Occupational Health & Safety Management Standards 3
M Which Version of 60601-1 to Purchase (IEC, EN, ANSI...)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M How to get an electronic version of IATF 16949:2016 which is Searchable IATF 16949 - Automotive Quality Systems Standard 8
E CER (Clinical Evaluation Report) MEDDEV Version 4 Template wanted CE Marking (Conformité Européene) / CB Scheme 5
B Where can I find an English version of Japan's PMD Act? Other ISO and International Standards and European Regulations 2
S Pre-release version of the upcoming AIAG FMEA Revision 5 FMEA and Control Plans 1
I ISO 22001 and ISO 22003 French version Food Safety - ISO 22000, HACCP (21 CFR 120) 2
D Referencing Standards in Procedures - Current version or actual? Document Control Systems, Procedures, Forms and Templates 6
K UDI "Version or Model" for Stand-Alone Medical Device Software US Food and Drug Administration (FDA) 6
R IEC 60601-1 4th Edition - Is a "Red-line" version available? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
R Current version of EN62304/A1 IEC 62304 - Medical Device Software Life Cycle Processes 5
Y Which version of ISO 13485 would be considered for MDSAP certificate? Canada Medical Device Regulations 8
G Insights into the 2016 Version of TS16949 (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 74
T Firmware version in EMC report / DoC CE Marking (Conformité Européene) / CB Scheme 1
M Current standard references IEC 60601:1988 instead of current version EU Medical Device Regulations 5
L Medical Device Software Document released version (article 5.8.4) IEC 62304 - Medical Device Software Life Cycle Processes 7
P Is an English version of CFDA YY0664-2008 available? China Medical Device Regulations 3
R Knowing when an EN version modifies the base standard CE Marking (Conformité Européene) / CB Scheme 14
C Registration to the 2015 Version of ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J How to document discontinuation or end of life for a software version ? IEC 62304 - Medical Device Software Life Cycle Processes 3
R EU updated borderline manual - version 1.16 EU Medical Device Regulations 2
Sean Kelley How to upload GM's MMOG survey version 4 to GM Powersupply Customer and Company Specific Requirements 3
V Locking in a Standards Version (ANSI Z1.4) Statistical Analysis Tools, Techniques and SPC 1
S Is Revision and Version the same in the Quality Manual? Quality Management System (QMS) Manuals 13
S Queries of new version ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S New FAA Form 8130-3 Effective 2/1/14 - Unlocked version attached Federal Aviation Administration (FAA) Standards and Requirements 3
K Medical Device Software Version Upgrade Regulation Impact 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T Zeiss, Calypso Software Version 3.8.10 Calibration and Metrology Software and Hardware 2
alonFAI Mechanical Drawing Version Change Document Control Systems, Procedures, Forms and Templates 8
J Quality Standard as part of our version of PPAP - Suggestions APQP and PPAP 1
M ANSI/ASME B1.2 Revision Changes from the 2001 version Various Other Specifications, Standards, and related Requirements 1
Similar threads


















































Top Bottom