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QMS set up for manufacture of medical device
Hi, -
Compliance with ISO 13485 or GMP for Class III device
Hello, There is a requirement for planning the plant for medical device class 3 production(dermal filler) another than ISO 13845? The plant will be under demand of ISO 13845 or under GMP demand? In Europe. -
Submission of Non-conformity Report
I work at a company here in Brasil.We are ISO 13485 certified and I would like to know where do we have to send the nonconformities report. It is written that the Recipient must be the National Competent Authority (NCA). -
Complaint Handling in ISO 13485
Hi, looking at your page regarding complaint handling for ISO13485:2016 but the article didn't state what section it was in? In 2003 it was part of 8.5.1 but there is no talk of complaints in 8.5.1 in the 2016 standard. -
Medical Device File
I never did ISO 13485: 2016 before and I would like to know what kind of Medical device file format. Could you pls. give me some example format. -
How long to keep prosthesis product in the even of knee transplant
How long we have to save prosthesis in case of knee transplant in India? -
Compliance of QMS and FDA 820
Just learning about different Quality Management Systems in college. I'm wondering if an Irish Company wants to sell medical devices into USA, is it enough for them to implement ISO 13485, or would they have to implement FDA 820 as well? Can a company have more than one QMS? -
Product Sample ISO 13485
Sir how long we have to save the sample product in case of ISO 13485 certified company/ -
Validation and Verification of Design and Development
Our company manufactures 1st risk class medical devices. For the moment we are improving our QMS in accordance with requirements of the new version of the standard. Especially we are wondering what should be considered as validation and verification of design and development. For example, we want to modify our existing device due to a request from a doctor or just add in our range of products something similar from competitors. Please give some examples of documents for this. Thanks! -
About Management Representative
Can there be 2 management representative for an organization?