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Home » Store » Medical Devices » Preparing for the EU-MDR Audit: Understanding New Requirements and Processes

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Preparing for the EU-MDR Audit

Preparing for the EU-MDR Audit: Understanding New Requirements and Processes

$397.00
Medical Devices

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Does your organization have the right strategies in place for a notified body (NB) review?

The EU-MDR is likely to be delayed for a year due to the COVID-19 pandemic. You need to understand how audits of your operation will be conducted under Article 10 — Obligations of the Manufacturer.

The Preparing for the EU-MDR Audit: Understanding New Requirements and Processes management report provides a detailed explanation of the quality management auditing requirements and processes created by the EU-MDR. The report is broken down into easy-to-follow instructions that teach you:

  • The key elements of a quality management system listed in Article 10
  • How to create an internal auditing plan that will help you prepare for NB audits
  • How to apply the requirements of Annex II to each of your devices or device families
  • The process of applying to a NB to conduct an audit
  • What technical documentation auditors will examine
  • What operations need compliance checklists and how to develop them
  • The roles and responsibilities of a devicemaker’s person responsible for regulatory compliance
  • Necessary qualifications of a person responsible for regulatory compliance

The report also offers other valuable resources including a summary of Article 10 — Obligations of the Manufacturer — cross-referenced to other articles and annexes along with a matrix of references to technical documentation throughout the EU-MDR.

Make sure you have the right strategies in place for regulatory compliance with the rigorous EU-MDR mandates! Order your copy today.

Who Will Benefit

  • Head of quality
  • Regulatory compliance manager
  • Designated person responsible for regulatory compliance
  • Auditors

PDF

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ISBN-13:
978-1-60430-131-1

Publication date:
May 2020

Page count:
39


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