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Difference (implementation-wise) between ISO 13485 and ISO 9001
What is the difference (implementation-wise) between ISO 13485 and ISO 9001, can the two QMS run together? -
Number of procedures required by ISO 13485:2016
How many procedures are required by ISO 13485:2016?
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Generating quality documentation
We are a startup and are all R&D personnel.
1. Can I generate quality documentation and have at least two other people in the R&D group review and approve them?
2. Can Quality Manual be revised as often as needed to reflect our developing stages?
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Is dental software considered as a medical device?
1. Is dental software considered as a medical device?
2. If yes do we need to approach Health Canada for Licensing as a medical device? -
Queries about ISO 13485
1. What is the basis of this business and the key point?
2. How to start easiest and how can we understand 13485
3. and how can we apply it completely easiest? -
Do I need iso 13485 for prosthetic liner manufacturing?
Do I need iso 13485 for prosthetic liner manufacturing?
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Gap analysis for ISO 13485
We have ISO9001:2015 is there an analysis of the extra requirements to achieve ISO13485:2016? -
Ionizing radiation doc
I have purchased an " ionizing radiation procedure" doc from your website 2-3 months ago. But I didn't get a supporting email how to fulfill the doc.
Could you please help me about this? regards -
Getting ISO 13485 - potential timeline and what is important
We got a reject of work related to lack of ISO 13485. I would like to have a feedback regarding what is important here and what potential timeline that might be - to get ISO 13485. -
Cleaning validation SOP for orthopedic medical device
what I am looking for Cleaning validation SOP for orthopedic medical device"