Posted by: @merzkrashed According to ‘Bonezone Article – Design Verification – Validation File’, and FDA definition for Verification ‘ Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled’ So, Why do you think…   Read more»

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 sometimes called a ‘sugar pill. Or a fake…   Read more»

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 sometimes called a ‘sugar pill. Or a fake…   Read more»

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 sometimes called a ‘sugar pill. Or a fake…   Read more»

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 sometimes called a ‘sugar pill. Or a fake…   Read more»

@merzkrashed great feedback.  Are you a product manager?  Some years ago I had the unfortunate experience of being apart of a product launch that was missing the product manager… I’m still not sure how that was supposed to work.  Needless…   Read more»

@merzkrashed great feedback.  Are you a product manager?  Some years ago I had the unfortunate experience of being apart of a product launch that was missing the product manager… I’m still not sure how that was supposed to work.  Needless…   Read more»

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 sometimes called a ‘sugar pill. Or a fake…   Read more»

Posted by: @merzkrashed Hi everyone, Let’s talk about how you can improve quality control department?Without quality control procedures, you could face product recalls or safety hazards that lead to expensive litigation.So, tell us about your ideas on how you can…   Read more»

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 sometimes called a ‘sugar pill. Or a fake…   Read more»

Thanks, @merzkrashed. Then, is it recommended to internal audit themselves and then hire an auditor?

@gh56 and @merzkrashed had talked about the 3 basic concepts of QM principles: system approach, process approach, and factual approach. I would like to add on some other principles that I think are also important: 1. Customer focus: it emphasizes…   Read more»

As @merzkrashed mentions the FDA “results of a process cannot be FULLY verified by subsequent inspection and test” and ISO “processes for production and service provision where the resulting output cannot be verified by subsequent monitory or measurement”. So if…   Read more»

I agree that it is important to have a good plan of how to handle testing failures when doing your V&V, but I like the points that @gh56, @merzkrashed, and @Sanam brought up, about spending more time on coming up…   Read more»

hi @merzkrashed, there are a few important points of information that if I were to sign an NDA form, I would definitely want to know in details: what information is considered confidential (definitions and boundaries), obligations/responsibilities or what might considered…   Read more»

I would like elaborate @merzkrashed‘s point about the FDA article “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications”. When determining risk, the FDA assessing the severity, type, frequency, and length of harmful…   Read more»

It was interesting to learn as @merzkrashed mentioned that the medical devices in India are largely unregulated. I came across this article/document which mentions that this is the case due to lack of medical device specific legislation on specifying standards…   Read more»