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ISO 13485:2016 regulatory expectations around distributors
What are the ISO 13485:2016 regulatory expectations around distributors?
Around distributor qualification, management, customer complaints, supply or QA agreements,
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Implementation duration
I have a question for you. I am experienced with ISO9001 and 13485. Conducted many audits as the company representative. I am working with a small startup site, no employees or equipment yet and am tasked with putting in a 13485 system in an ISO8 cleanroom operation. Using your toolkit and no employees, other than a few senior leadership individuals who will not help much, how long should I allocate to getting all the procedures in place to pass an audit? -
Question about SaaMD
Is your toolkit for MDR compliance optimized for software as a medical device?
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Rework requirements
Under what circumstances a medical device which has already been put into service can be returned by the user or patient to the manufacturer to be repaired or modified? Does this trigger any documentation or procedures to be in place? What are the risks?
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MDR Labelling
For a company that manufactures textile medical devices having all the required information but the date of manufacture (the expiration date is not applicable) on a woven label which is directly sewn onto the medical device, is it acceptable under the MDR to have the date of manufacture printed on a sticker label which will be placed on the device`s first level of packaging - plastic bag (every device is packaged individually)?
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Auditing and creating checklist for medical device labeling
How to audit and create a checklist for medical device labeling including advertising and claims?
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Most difficult issue and challenge during initial implementation
What would be the most difficult issue and challenge during initial implementation?
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PMS process
I am new to the PMS process, we have our procedure and plan in place for a class i medical device. Is this template the report that will be submitted for the audit? or this this report tempate just to be used for PMS reviews?
Also can data be analysed in terms of figures (i,e percentages) or can it be presented in graphical form with appendices?
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Necessity of MDD and MDR for contract manufacturing companies
can you shortly explain the necessity of MDD and MDR for contract manufacturing companies which not sell their products to foreign countries but germany only? -
How a repair under the ISO 13485 can be deemed acceptable?
i would like to understand how a repair under the iso 13485 can be deemed acceptable for another manufacturers CE marking when the same processes have not been certified by the OEM company