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What in ISO 14534: 2015 should be applied to contact lens care products?
I am interested in the following:
What is it in ISO 14534: 2015 that should be applied to contact lens care products and not found in
93/42 /EEC? -
Performing validation of process/activity
How to perform a validation of the process/activity?
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Implication of EU MDR Deadline on 26th May 2021
Given that the new implemetaion date for the EU MDR is 26th May 2021, if this is not further postponed, would it imply that CE certifcations for all devices under MDD must be recertified under MDR before being allowed to import and sell in the EU?
Is it applicable to all classes of medical device?
What happens to the products that are already in the market/ in the stores or warehouses?
How would importer/wholesalers/end users find out if their products are CE certified under MDR? -
Inventory management
How is inventory management written in the ISO 13485?
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Necessary facility requirements to build medical devices
What facility requirements are necessary to build medical devices. (White rooms, etc.)
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Can ISO 9001 lead auditor audit ISO 13485?
Am a lead auditor in ISO 9001:2015 can it be difficult for me to audit the ISO 13485
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Other ISOs used by the medical devices
Aside from ISO 13485 what are the other ISOs used by the medical devices?
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Necessity of implementing ISO 14971 to obtain ISO 13485
Hi Kristina. Is it necessary to implement ISO 14971 to obtain ISO 13485:2016 if the company already has a risk management process (as per ICH Q9)
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MDR QMS requirements
'm looking at your MDR QMS requirements table and I have a feeling it doesn't refer to all the correct MDR requirements i.e. Resource management (ISO 6) in MDR is states something about the control of suppliers and subcontractors... that's not resource management, same with A strategy for complying with regulations that's not 7.2
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Training Validation for ISO 13485
I'm wondering how in depth I need to be in regards to training validation. Our training consists of reading the SOPs, and then signing off on their personal training records. My predecessor suggested creating an assessment quiz for each SOP, but it seems a little more labor intensive than the standard requires. I am thinking it might be more beneficial to create QMS assessment quizzes for certain processes (manufacturing dept, shipping dept, etc.) and then testing on a quarterly basis for comprehension and retention. ISO 13485 doesn't specifically say how this should be handled. I would appreciate any suggestions or feedback. Thank you!