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Main challenge stat up companies face to comply with ISO 13485
What is the main challenge stat up companies face to comply with ISO13485?
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Clean room requirements standards for ISO 13485:2016
What are the cleanroom requirements standards for ISO13485:2016? -
Documents required by MDSAP and FDA in ISO 13485 Documentation Toolkit
1. Do you have in your 13485 & MDR package documents required by MDSAP? If no, where I can get them. 2. The same question about your 13485 & MDR package documents required by FDA?" -
Documented checklist for SaMD
I have started worked with software base medical device company , i have to implement ISO 13485 for SaMD and i am new for software base medical device work , can you help me for documented checklist for SaMD -
Preparing Medical Device File
I like to prepare a medical device file from initial as i have starting manufacturing the medical device so please help me!!
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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?