This webinar provides an audit report template and teaches auditors how to conduct technical file auditing for compliance with Regulation (EU) 2017/745.
This is a new webinar intended to teach internal auditors and consultants how to perform a thorough audit of CE Marking Technical Files against the requirements of the new European regulations–Regulation (EU) 2017/745.
With access to this training webinar, we are also providing native presentation slide deck, and an audit report template including checklist items for each of the requirements in Annex I, II, III and IV of the MDR.
We also provide an exam (i.e., 10-question quiz) to verify training effectiveness for internal auditors performing technical file auditing. If you submit the completed exam to us by email in the native MS Word format, we will correct the exam and email you a training certificate with your corrected exam. If you have more than one person that requires a training certificate, we charge $49/exam graded–invoiced upon completion of grading.
This webinar provides an audit report template and teaches auditors how to conduct technical file auditing for compliance with Regulation (EU) 2017/745.
If your firm is preparing for compliance with the new MDR, you might also be interested in the following information provided on this website:
- A CE Marking procedure that includes templates for the Essential Requirements, Declaration of Conformity and a Technical File Index.
- A blog outlining how to create your own Quality Plan for compliance with the MDR
- A blog explaining three major differences between the requirements of a Technical File for CE Marking and a 510(k) submission
- An 8-part webinar-based course reviewing the requirements of Regulation (EU) 2017/745 and comparing the requirements with the MDD (93/42/EEC as modified by 2007/47/EC).
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