Institute for Medical Device Compliance & Regulations
ISO 13485
News
Risk Management according to ISO 14971
12
Aug, 22
In a fast-paced world, the risks companies are exposed to
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What risk-based approach to QMS means?
11
Aug, 22
The new version of the ISO 13485:2016 standard expects companies
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Traceability Matrix Best Practice
5
Aug, 22
Traceability is at the heart of the product development process
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Writing ISO 13485 Quality Manual – Need a tip?
1
Aug, 22
A quality manual is a document that outlines the company’s
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The importance of the Quality Manual?
25
Jul, 22
Quality systems, like everything in the regulatory world, have a
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Start using eQMS today
13
Jul, 22
As a start-up, you probably face challenges of how to
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