Posted by: @jaf22 In the world of medical devices, there is no such thing as a waste of money for risk assessment. When a device deals with aiding in human function with direct contact to user, then ...

Posted by: @tulikadasp To make sure medical devices remain safe and effective once it’s on the market - medical post-market surveillance (PMS) is done. It a system that provides continuous feedback a...

Posted by: @lmathis When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting? I think that risk in medical device developme...

Posted by: @jtl27 This week's discussion reminds me a lot of what we had to learn in our capstone design class senior year. The three biggest deliverables for that class other than our powerpoint pre...

Posted by: @rv347 In design controls, there is the DID and DSD documents. DID is design input and gives a broad description of the product (ex, "red knob"), whereas the DSD is design specification an...

Posted by: @kbentleymsm-edu Consider the Design Controls lecture that Dr. Simon has made available. Yes, we know that all parts work together to support the goal of medical device development. What...

Posted by: @merzkrashed According to 'Bonezone Article - Design Verification - Validation File', and FDA definition for Verification ' Verification means confirmation by examination and provision of ...

Where I work, there is always a discussion about if a test method being used in R&D of a product should be validated. Test method validation is used to identify the variation present within a test...

In my line of work, one type of validation that is done is Test Method Validation. This is done to identify any variation that may be present within a test method and if a method is validated, it is c...

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: @amd29 When a medical device is clinically tested it is to evaluate the safety of such a device on the human and whether or not the desired result will be obtained from doing the clinical ...

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: @smitshah Especially in medical device companies when product are in developing stages how can a company like verb or ethicon which are working on new technology or are about to launch a n...

Medical device companies typically tend to market products to their primary consumers, doctors and hospitals. In the case of dental tools, oral surgeons, dentists, and hospitals would be the primary c...

@hodafattel I think you raise valid points about how the internet has changed traditional retail businesses, however, I think that there are some differences with how the internet has effected the med...