Software Medical Device Regulation Specialist
Mihai S Dobre
4.25
(8)
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Expert in EU MDR, ISO 13485, ISO 14971 and IEC 62304, as well as software MDCG and MEDDEV guidelines.
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ChatGPT Bot
Custom bot powered by ChatGPT technology. May behave differently from regular ChatGPT.
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Created by Mihai S Dobre
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Try These Prompts
Click on an example to start a conversation:
- What standards do I need to comply with for EU MDR certification?
- What are the rules for classifying my software medical device?
- Describe the MDCG Guidance (MDCG 2019-11) to help me take a decision on the qualification and classification of my software
- Describe in details the software cybersecurity guideline
- Explain each of the ISO 13485 clauses.
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