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Medical devices
Are medical devices subject to the falsified medicines directive (tamper proof and individual serialisation) or are you aware if this is the long term plan for them to meet this requirement?
https://www.gov.uk/guidance/implementing-the-falsified-medicines-directive-safety-features
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Determining scope of certificate for company that outsources production processes
How do you determine the scope of a certificate for a company that outsources production processes?
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Good Manufacturing Practice in pharmaceutical
We are looking for guidance with regards to Good Manufacturing Practice. Is this a certification that pharmaceutical companies need to apply for? How do they apply? If the company has ISO13485, can they use the GMP mark? or do they need to be registered for GMP?
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Adverse Event Reporting
Hello
As a distributor of medical devices, if there is an adverse event, would I need to report it to the MHRA (we are UK based) or would that be the responsibility of the manufacturer?
thanks
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Specific requirement to provide After-Sales Service
I was wondering, according to MDSAP/ISO 13485 or Health Canada regulation, is there any specific requirement to provide After-Sales Service or spare parts for specific time (such as 10 years /20 years)?
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Is technical file of device mandatory to put on device on market?
I was reading the full text of MDR, in this regard, if I have correctly understood: the technical file of the device is mandatory to be registered by an EU manufacturer or its representative. Once this is done in the EU country of the manufacturer or representative, the device can be put on the market in ALL EU countries (not only the country where it was registered). Am I right?
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Applying Project Checklist for ISO 13485:2016 Implementation in a food processing organization
Can you apply your Project Checklist for ISO 13485:2016 Implementation in a food processing organization?
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Mandatory information in Conformity Declaration for Medical Device Class I
Hello, I have a Conformity Declaration from a supplier for MD Class I non-sterile, under MDR 2017/745, that identifies the product with "name", "model" (uses the references of the products), "GMDN" and "Classification" (Class I). There is already a text field for "Basic UDI-DI", but is still empty. Recently I asked for a new product class I with a new reference, produced only for us. I asked for an update of the Conformity Declaration and the supplier told me the one I have is enough for the new reference because it is under the same "Name" and "GMDN". Is that correct? Doesn't the MDR oblige to an "unambiguous reference allowing identification and traceability of the device", for this one in particular? Shouldn't the supplier add the new "Model"? Additionally, when will the Basic UDI-DI be mandatory in these declarations? Thank you, Isabel Sottomayor -
ISO 13485 Internal Auditor
As I work through the course material it is becoming increasingly clear that as a small company like mine-my ability to act as an internal auditor may not be feasible as I cannot audit the processes I am involved in. I am also Purchaser and QMS Manager.
It would not be possible for another member of my team to audit purchasing processes as they are not qualified. We received a finding on a past audit as our Internal Audit was deemed unqualified.
Please advise how other small companies navigate this situation. -
Do we need ISO 13485?
We are a manufacturer of cleaning chemicals, some of which are used in the medical industry, for cleaning medical devices, apparatus, equipment, etc.
We have always been led to believe that we needed to adhere to ISO 13485 however, upon reading the document, I am not sure that it applies to us. Can your expert provide further clarification please?