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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? -
Cleaning of laboratory instruments
I am wondering how to registrate the cleaning of laboratory instruments. Currently we send out a reminder but we would like to have a form in which we can see at what date instrument is cleaned in stead of eg a two monthly reminder of all instruments in a certain part of the lab. So my question really is whether such a registration is necessary or what is really required by the ISO 13485? -
Requirements for ISO 13458 implementers
"I am offered to take on a role in certifying our company to ISO 13458. I do have extensive experience in ISO 9001:2015 and I have had the training from AQS ANSI certificate. Do I need to take a course to transition our new company or is there a feasible approachable way to do so at minimum cost?” -
Requirements for infrastructure
Regarding the ISO 13485:2016 PR 05 Procedure for Infrastructure and Work Environment: 95% of our business is repair of surgical drills and saws. The other 5% of our business is contract manufacturing for OEM surgical device makers. We do not manufacture complete medical devices in our facility. We do not have clean rooms, and we don't test our air quality for microbiological or particulates. What all is actually required in our procedure as far as the standard is concerned?