Module 5 Presentations

16/07/2024

ISO Device Standards

13485 + MDR + 14971

9001

Quality and Regulatory

17025 15189 10993 Biocpt

60601 elec 62304 s/w 62366 use

Lab Testing

14155

20916

Clinical Testing

The Organisation for Professionals in Regulatory Affairs

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Exercise. Create a four line rhyming paragraph for one of the ISO standards.

ISO 13485 sets the standard high, For medical devices , it's a guide. Quality management is the key, Ensuring safety for you and me.

The Organisation for Professionals in Regulatory Affairs

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