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CE Mark
We would like to inquire after regulations / requirements needed for a patient controlled analgesia pump. Is there a guideline that needs to be followed or adhered to in order to get the CE mark on a product?
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Equipment Qualification vs. Process Qualification and Process Validation
I am trying to get a better understanding about the guidance on Equipment Qualification vs. Process Qualification and Process Validation. Can you refer me to the sections of the standard that speak about those topics?
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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