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CE mark
For the purpose of the CE mark, our consultant prepared a post marketing surveillance (PMS) document and said that I should have (as part of the 13485) a procedure for how to prepare such a document. According to the post marketing surveillance document that our consultant prepared, I see that parts of this documents is based on procedures that are listed in different documents that you have provided (e.g., 08_Customer_Complaints_and_Feedback, 16_Adverse_Event_Investigation, and 15_Nonconformities). I wonder if you have a single document that describes the procedures for a PMS review. -
Document control version question
I am hoping that someone can help me with a question about document control for ISO 13485. With version control you give examples in the documentation as per below:
With regards to the versions above, there is a document on version 1.2 and another on 0.6. When changes are made how are you suggesting document version is changed? Does it go from 0.0 to 0.9 and then go to 1.0? Or are minor changes illustrated by the .X number and major changes be a whole numerical shift from 0 to 1? The procedure doesn’t explain this hence me checking. And if it is the latter, how should I distinguish between a minor change and a major change?
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13485 Implementation
My background in 13485 was within a manufacturing company that produced medical devices. I have now been tasked with implementing a 13485 QMS where there is no physical product. The offering facilities and services but no commercialised product. How would I tailor the 13485 standard to a facility and service when it is very strongly worded towards having a product? -
New EU MDR - Technical File new document format
Hello, I am working on the TF of a Class IIb device new document format to be compliant to new EU MDR regulations. I am at section Product and Design Specifications - USER REQUIREMENTS. My question is: what do they mean by User Requirements? the question is not specific enough. thank you for your quick response. Taly Bendayan -
Acceptable or Not Acceptable
hello quick question, Acceptable or Not Acceptable When taping an entry in a lab notebook, Is hash marks (") acceptable on the taped entry. I'm used to name and date, but I am at a new company and they use (") -
CE Marking
Hello, I was hoping someone could advise me on an issue with CE from a complaince perspective. A manufacturer I use has a valid CE certificate until the end of June 2022, they have told me the renewal is going thorugh, but due to new laws it is more complicated and they may not be able to obtai the renewal until the end of July. But they are sure there will be no issue. I have two questions: 1 - Bewtween the end of June and when they get the renewal, can I sell the products I hold that were manufactured under a valid CE, even though it will be out of date? 2 - If I purchase new products that have been produced without a valid CE, they will not be compliant will they? Thank you -
Production Part Approval Process
I am working for a Medical Devices Company already certified to ISO 13485. Where does (PPAP) Production Part Approval Process fit in please? -
Single Registration Number for MDR
What is considered a Single Registration Number for MDR? How do you acquire it? I have a UDI for each product and Device Nomenclature Codes(GMDN) -
Design and Development Agreement
Do you have a template for "Design and Development Agreement". I mean for outsourced process? -
Design and Development Agreement
Do you have a template for "Design and Development Agreement". I mean for outsourced process?