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Is the Technical File still a requirement?
Is the Technical File still a requirement? I do not see any mention to this in the updated ISO 13485
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ISO 9001 and ISO 13485 PMS
Hi we are aiming at obtaining iso 13485 and 9001. Only one part of our complete product is MD1 ()medical device class 1.) so majority of product will fall under 9001 and minor part under 13485. However. When performing PMS/PSUR- do we need to perform it on the complete product or only on the part that is medical device?
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ISO 13485 and cleaning process
I need what ISO 13485 says about cleaning process.
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MDD to MDR Transition
My company recently had an MDD Tech File audit come from our notified body with 4 major and 3 minor nonconformities. Our CE Mark expires April 17, 2021. Can we move to another notified body and work with them on getting our CE Mark under MDR rather than clearing nonconformities with the first notified body. We understand our CE Mark will be under suspension until we comply with MDR.
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Using certified contract manufacturer impact
We are set to produce our medical device through a contract manufacturer who holds ISO 13485 and ISO 9001 certifications. How does our use of a certified contract manufacturer impact what is required of our company regarding MDR / CE Mark?
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ISO 13485 documentation question
if we are only a distributor but may have to register products in the future would be these be the files that we would need
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Monitoring and Measurement / Environmental Controls
I was hoping that you could clarify something for me that I am struggling to find information on.
We have been completed 200 surface samples, all but 1 have been within our established criteria. If I select critical areas, can I only test those specific areas ? -
Gaining best skills as auditor
what technique will make a new auditor to gain the best skills with limited resources?
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MDR Accessories
Please could you provide advise on the following situation: If a part of a medical device is attached to the device, it becomes a component, but if the same part is provided separately to the user in order to fulfil the medical device`s intended purpose, it becomes an accessory. Is that correct? Considering the scope and requirements of the MDR, the components are a part of the medical device itself which goes through the certification process. If the components are manufactured in bulk, kept in stock, and attached to the final product to fulfil the orders requirements, is it required for them to have the date of manufacture on them, or would the date of manufacture provided on the medical device itself would suffice? How about the accessories? Do they need to go through the same process as the medical device itself (e.g. have clinical evaluation, technical documentation, DoC, UDI, labelling in compliance with the MDR, PMS, etc.)? If in order to fulfil an order they are supplied separately and additionally to the medical device itself - in a separate bag, would the accessories need to have their CE mark, date of manufacture, and/or serial number on their label in order to be compliant, or is this not a requirement?