Preparing for the EU-MDR Audit: Understanding New Requirements and Processes
Product Details
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
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ISBN-13:
978-1-60430-131-1
Publication date:
May 2020
Page count:
39
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