I think Design Reviews are value adding in a sense that they act as a central node (or convergence) of the documentation and design decisions - afterwards, a sort of divergence takes over until the next Design Review. Having held many Design Reviews the past years, I seem to struggle with conveying the value of the meeting to many of my stakeholders. I use terms the same as you: “pause”, “reflect”, etc., however, when talking to a specialist, they are sometimes used to / expects to run through each requirement in a detailed manner (much like a Technical Review), and if not: “then what is the value other than sitting and talking at a very high level?” That being said, I experience that most (not all) stakeholders see the value after the Design Review has been held, and they willingly participate in subsequent reviews. Thank you for a good and concise presentation - I am happy to see, that I use the same approach as you :)
Thanks for the comment Mikael. Sometimes I use the technical and very detailed reviews as input to the design review. That way you can bring issues that are on a very granular level, but may critical to the overall project's success to the design review.
Hi Peter and thanks for your video on Design Reviews. I would like to know whether the technical reviews should be part of the Quality Management System and the Design History FIle. Technical Design reviews are used to show technical aspect of the design and they are prerequisite for the design reviews. But do we need to include them in the DHF ? If not how can we show that the technical aspects have been evaluated solved?
What should be the content to be covered in design control for prefilled syringes with passive needle guard? Is it necessary to have design review for this device?
The information provided is not sufficient to answer the question. What you are referring to is most likely a combination device? But it could also be a medical device depending on what is in the syringe.
I have an assignment on medical device design control I know all the definitions but dont know how to apply on a specific product Like ventilator Can u plz help me Thanks
Can you explain in more details what is the role of the indepedent reviewer during the design review ? We don't have this requirement in Europe. Thank you.
A short way of explaining is to think of it as the combination of two idioms: Playing the "devil's advocate: "...a situation where someone, given a certain point of view, takes a position they do not necessarily agree with (or simply an alternative position from the accepted norm), for the sake of debate or to explore the thought further using valid reasoning that both disagree with the subject at hand and proves their own point valid." Can't see the forest for the trees: "An expression used of someone who is too involved in the details of a problem to look at the situation as a whole."
@@MedicalDeviceHQ thank you for your answer. Do you advice companies to choose external person or is it possible to choose someone in a departement not involve in the design ?
@@delphinemercier5382 it depens on how big your company is and what resources you have at your disposal. So it all depends. But do keep in mind that the "independent person" shall be at least as skilled in the art as the persons creating the design.
I think Design Reviews are value adding in a sense that they act as a central node (or convergence) of the documentation and design decisions - afterwards, a sort of divergence takes over until the next Design Review.
Having held many Design Reviews the past years, I seem to struggle with conveying the value of the meeting to many of my stakeholders. I use terms the same as you: “pause”, “reflect”, etc., however, when talking to a specialist, they are sometimes used to / expects to run through each requirement in a detailed manner (much like a Technical Review), and if not: “then what is the value other than sitting and talking at a very high level?”
That being said, I experience that most (not all) stakeholders see the value after the Design Review has been held, and they willingly participate in subsequent reviews.
Thank you for a good and concise presentation - I am happy to see, that I use the same approach as you :)
Thanks for the comment Mikael. Sometimes I use the technical and very detailed reviews as input to the design review. That way you can bring issues that are on a very granular level, but may critical to the overall project's success to the design review.
Hi Peter and thanks for your video on Design Reviews.
I would like to know whether the technical reviews should be part of the Quality Management System and the Design History FIle. Technical Design reviews are used to show technical aspect of the design and they are prerequisite for the design reviews. But do we need to include them in the DHF ? If not how can we show that the technical aspects have been evaluated solved?
What should be the content to be covered in design control for prefilled syringes with passive needle guard?
Is it necessary to have design review for this device?
The information provided is not sufficient to answer the question. What you are referring to is most likely a combination device? But it could also be a medical device depending on what is in the syringe.
I have an assignment on medical device design control
I know all the definitions but dont know how to apply on a specific product
Like ventilator
Can u plz help me
Thanks
Hi Maryam,
I am not sure how I could help?
/Peter
Can you explain in more details what is the role of the indepedent reviewer during the design review ? We don't have this requirement in Europe. Thank you.
A short way of explaining is to think of it as the combination of two idioms:
Playing the "devil's advocate:
"...a situation where someone, given a certain point of view, takes a position they do not necessarily agree with (or simply an alternative position from the accepted norm), for the sake of debate or to explore the thought further using valid reasoning that both disagree with the subject at hand and proves their own point valid."
Can't see the forest for the trees:
"An expression used of someone who is too involved in the details of a problem to look at the situation as a whole."
@@MedicalDeviceHQ thank you for your answer. Do you advice companies to choose external person or is it possible to choose someone in a departement not involve in the design ?
@@delphinemercier5382 it depens on how big your company is and what resources you have at your disposal. So it all depends. But do keep in mind that the "independent person" shall be at least as skilled in the art as the persons creating the design.
Really good to have.
Thanks Siva!
طلب صداقه من صاحب صوره عبودى المهاب أج حلم حلم حلم حلم حلم حلم حلم حلم حلم حلم حلم حلم حلم حلم حلم حلم حلم حلم حلم