Institute for Medical Device Compliance & Regulations
ISO 13485
News
Explained: Planning of product realization in ISO 13485 (Part 2)
7
Oct, 23
In the ISO 13485:2016 standard is written what should be
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Explained: Planning of product realization in ISO 13485:2016 (part 1)
26
Sep, 23
This chapter of the standards explains how one medical device
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What are Product Review Requirements as per ISO 13485
6
Dec, 22
The purpose of the requirements review related to the product
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What are the Outputs of Design and Development
10
Oct, 22
The ISO 13485 standard requires the medical device company to
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Infrastructure requirements in ISO 13485
29
Sep, 22
Infrastructure in ISO 13485 is meant workspaces, process equipment, buildings,
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Human resources in ISO 13485
16
Sep, 22
This part of the standard explains how employees whose actions
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Can my medical device be produced by a non-ISO 13485 certified manufacturer?
24
Aug, 22
To have or not to have? To certify or not?
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There is a better way to organize your folders!
23
Aug, 22
Small businesses collect numerous kinds of information - financial, employees,
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From paper-based to eQMS – Problem naming files
22
Aug, 22
Sustaining a paper-based quality management system is pretty hard and
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Want to apply risk-based thinking? This you should know
15
Aug, 22
ISO 13485:2016 requires companies to use risk-based thinking to manage
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