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next year in May the new European ndr will take effect a lot of companies that currently have si marketing or struggling to try to update all the documentation to the new MDR requirements not only do they have to update all their procedures to comply with the new MDR requirements but they also have to update their technical file documentation and one of the tasks that were going to expect auditors to be looking for when they come to do a CE Marking audit is to see if the companys actually conducted an internal audit of the technical files after they were updated its its not enough just to update them but you also have to show that youre auditing your systems as well so I have a lot of companies coming to me now and asking if I can do a technical foul gap analysis and a quality system gap analysis and Ive come up with this fairly straightforward system for performing the gap analysis of the technical files and I thought Id share that with companies they thought it might be helpfu