Posted by: @cef3 So there may be more than just the 3 main organization types that Dr. Simon presented in the lecture: Say you were to start up a medical device company that will function worldwide....

Posted by: @savery115 A small part of the lecture reviewed Upper Management vs Middle Management. Upper Management people are strategic and tend to set the groundwork and vision for what the company ...

Posted by: @fo3 As we know, forming a project team is partly making sure every member is working toward the same goal(s). Each member should be able to contribute something valuable to the project ac...

Posted by: @vnd4 Risk management is the process of analyzing, identifying and responding to risk factors. Managing risks early is the best way to avoid issues later on. Throughout the R&D stage, ...

Posted by: @traceymraw Similar to the scalpel example in the lecture, I think there are many surgical tools where the risk must be accepted. For tools such as bone drills and saws, taking away the d...

Posted by: @fgk4 The ISO 14971:2012 "Risk management for medical devices" requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundr...

Posted by: @la82 As mentioned in other discussions, design control is an integral part of any medical device design, and its benefits are clear. However, what are some of the issues that arise of the...

Posted by: @amandaally1029 Verification is an important part in developing medical devices or products, and can really help in making sure the products set out to do what they are supposed to. For in...

Posted by: @smk45 While watching this week's lecture on design control, I tried to figure out the main difference between Design Verification and Design Validation. Both are used to make sure that th...

Posted by: @hg93 “Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied...

Posted by: @rgp29 Hello everyone, I have noticed how Dr. Simon keeps pointing out to importance of taking minutes in all the meeting of the team. I never really thought of how important they are. Bef...

Posted by: @hg93 As mentioned in the lecture, design review meetings happen at the end of each stage in the project. They are critical because they facilitate communication between the design team, m...

Posted by: @merzkrashed As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or someti...

Posted by: @amandaally1029 With clinical studies comes lots of risks, especially where human participants are concerned. However, in order to figure out if a medical product, device, or drug is essen...

Posted by: @smitshah I cant really think Why is it needed to use double blind study since I think single blind i.e. only patient blind must work.In double blind both Investigator and patient will not...