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introduction to ISO13485 quality

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Summary the agenda, requirements, and the certificate of the ISO13485 quality

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ISO 13485
Phan Minh Tam 20191375
Lecturer: Pof. Nguyen Minh Tu
Quality of management in
Pharmaceutical & Food Products

, Medical devices

Agenda - Quality management systems
- Requirements for
regulatory purposes

ISO 13485 is the medical
industry's optimal medical device
standard, which ensures that all
medical devices meet the proper
regulatory compliance laws and
customer needs

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January 13, 2024
Number of pages
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Written in
2022/2023
Type
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