Posted by: @orleron Well, you did it! You made it to the end of Medical Device Development. The original intent of this course was to teach you what professionals in the medical device field do in th...

Posted by: @kbs27 Hi all, In the video lecture Dr.Simon mentioned about two terms of contract,Written & Verbal agreement. He said that verbal contract can be legal but what if the due to dispute ...

Posted by: @amd29 Quite recently Dr. Simon organized us into project teams. And strangely, I became a part of one before I knew it. The approach of forming the team was weird.Personally, after experi...

A Risk Management File (RMF) is where you keep risk management activities, documentation, and records. A Risk Management File contains proof of Risk Management Plan. Hazard Analysis, Hazard Evaluation...

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 would say anything with pointy or sharp end...

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: @tulikadasp Product development is inherently an evolutionary process. While change is a healthy and necessary part of product development, quality can only be maintained if those changes ...

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: @jr377 This year, the Right to Try act was signed into federal law. This law allows patients to request the use of investigational drugs (without FDA involvement or state law). There was a...

Posted by: @savery115 Clinical trials and research is designed to expose a limited sample of subjects to potential new treatments. Human tests of a medical intervention typically pose risk to subject...

Posted by: @mejefferson During the current pandemic, there are over 100 vaccines being tested on humans worldwide. The average human today is a subject for a vaccine. Do you think that different vacc...

Posted by: @jailynp26 YES! research market is needed because it can show you what people are interested in at that time. It can show what is missing from the scenes was well. Focusing on what people ...

Posted by: @sahitya-sadineni After watching the videos from this week's lecture, we have learned about the various company types. While thinking about this, would you consider turning down a position...

Posted by: @sahitya-sadineni In my personal opinion, partnerships and sole proprietorship are very similar but with lower risk when investing due to the split of initial costs for partnerships. Partn...