I should have attached the risk traceability matrix I discussed. Here it is along with other items to show visually the inputs to Risk Analysis. ------------------------------ Edwin Bills Edwin read more
Unfortunately I have come on to this discussion late in the process. There have been some excellent responses by Peter and Edward, but I saw one this that I may need to clarify. As an example I can read more
Hi Noa, not neccessarily. Only when those documents need to be updated (e.g. because a design input requirements is changed, or an additional risk control measure is identified and added as design input read more
In addition to Kevin's excellent response, there is one more consideration, the Risk Management File must be maintained over the entire lifecycle of the device, according to ISO 14971. Is there an obstacle read more
Yes. However, under these circumstances it is very important to understand the equipment that will be used and its qualification for performing the testing, especially if it is an endpoint of the study. read more
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Hello RAP Community! My name is Angelina Huynh, and I'm an early career professional specializing in sales and marketing within the biologics CDMO and CRO industry. Currently, I'm studying for the RAC-Drugs certification to deepen my understanding of ...
This message was posted by a user wishing to remain anonymous A manufacturer of medical devices is contemplating to sell the intellectual property and commercialization rights of a medical device to another company. However, the original developer will ...
This message was posted by a user wishing to remain anonymous A manufacturing company is being acquired through a process where the old company (OLD-comp) will no longer exist while a new one (NEW-comp) is created to continue doing the same manufacturing ...
T here’s limited regulatory guidance on gene therapies for many drug manufacturer s and how i t can be a struggle to develop successful strategies for CMC. At this upcoming RAPS workshop , @Janmeet Anant will ...
The Commission has harmonized the next group of standards for the purpose of Europe's MDR and IVDR Article 8 harmonized standard provisions. For the MDR, these are harmonized standard entries No. 18 through 25 and they relate to medical gloves, biological ...
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