Pzimmermann92
Starting to get Involved
Good day everyone,
I am implementing actions on our QMS regarding the MDR gap analysis according to our MDD (legacy) device.
Regarding the Clinical evaluation, there is a need for for a literature search and review protocol + a literature search & review report.
how often should this review be performed/conducted? only when there is a need for an update of the CER where the clinical data/literature should be an input for?
Or as i have read on similar places, whenever there is new data availability, (but as it is not practicable to check everyday for new data, perhabs 2x per years is a good interval? or is it sufficient enough to perform the review @ an CER update interval (or when needed)?
Question 2: The PMS should also be kept up to date, as far as my understanding the literature search is also an input for PMS? Or is it more a good way to go, to look for literature periodically (regarding PMS activites, through a sepreate literture search (besides the search and review protocol)? just as this statement says: "Manufacturers should proactively collect PMS data from their device as well as from competitor devices. Manufacturers can do this by searching for additional literature or looking into incident databases".
So the key questions are, how often should a literature search and review protocol + the evaluation be performed? @ every PSUR and or Clinical evaluation update, or more often?
And should PMS data be searched through this protocol, or via an alternative route?
I could not find sufficient or detailed answeres over the internet so thats why i came here for some help.
Thank you very much in advance!
Best regards, Patrick Z.
I am implementing actions on our QMS regarding the MDR gap analysis according to our MDD (legacy) device.
Regarding the Clinical evaluation, there is a need for for a literature search and review protocol + a literature search & review report.
how often should this review be performed/conducted? only when there is a need for an update of the CER where the clinical data/literature should be an input for?
Or as i have read on similar places, whenever there is new data availability, (but as it is not practicable to check everyday for new data, perhabs 2x per years is a good interval? or is it sufficient enough to perform the review @ an CER update interval (or when needed)?
Question 2: The PMS should also be kept up to date, as far as my understanding the literature search is also an input for PMS? Or is it more a good way to go, to look for literature periodically (regarding PMS activites, through a sepreate literture search (besides the search and review protocol)? just as this statement says: "Manufacturers should proactively collect PMS data from their device as well as from competitor devices. Manufacturers can do this by searching for additional literature or looking into incident databases".
So the key questions are, how often should a literature search and review protocol + the evaluation be performed? @ every PSUR and or Clinical evaluation update, or more often?
And should PMS data be searched through this protocol, or via an alternative route?
I could not find sufficient or detailed answeres over the internet so thats why i came here for some help.
Thank you very much in advance!
Best regards, Patrick Z.