When you go to work for a company that requires you to sign an NDA, or you are a company looking to hire employees under a nondisclosure agreement, you will generally see at least five basic elements in the nondisclosure…   Read more»

The best thing about this course is that it gives us (students) the practical feeling and more understanding about the industry and how it works. Rather than other courses, it gives us opportunity to work in a team and how…   Read more»

I think that is little absurd that physician’s wife meal is not getting paid off. But then again why is physician’s wife in the meeting? I mean usually these meetings are highly confidential so personally I don’t understand the whole…   Read more»

The main difference is that written can be proven in court while oral might be little harder to do so unless you have a witness. Even then it might be tough. I don’t think it is wise to start up…   Read more»

Just like you, I have worked in both the structure too. In my opinion, I definitely liked the small organization where everyone is doing everything. Because, in the absence of one, other knows what is going on and how to…   Read more»

I would consider a Product Organizational Structure for collaboration projects. In this structure, managers report to head of the company and analysts report to managers. Their main idea is the product line. Therefore, their main goal is product line too….   Read more»

In my opinion, it should be both. Having departmental knowledge is very crucial in forming a team since that person needs to know in and out about every little thing about the department and how to do it. But when…   Read more»

Documentation review is one of the main risk management analysis. Since the place I work uses all written documentations and no electronic, documentation review and should be under FDA regulated therefore, documentation review is very very important.

Calibration, maintenance, safety inspections, regulations and standards all cost money but they are necessary to do it. Subscribing to these databases are simply an indispensability. If they are not charged then corners will be cut and for standards of this…   Read more»

Factors contributing the risk index numbers can be divided into three different group: A. Overall context such as scientific unknowns, varying susceptibility to risk, positive feedback, and loss of safety margins. B. Human factors such as social dynamics, conflicts of…   Read more»

I dont think I would give any option low severity because in risk management everything is equally important. You can not have less acceptance while moderate high mitigation. But I would definitely give highest severity to transference. DUring anytime in…   Read more»

Risk management is not a lifecycle process! I totally agree to this that company should take care of risk management not only in the beginning of the production but during entire time of the production. Biggest example of this is…   Read more»

Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. medical devices). Because design controls…   Read more»

There are bunch of medical device that does not need clinical trial. Anything that has external use usually does not need medical device such as stretcher, medical gloves, assistive cane, walker, and other bunch of them.

Issues with design controls: · assessing new product ideas · training and retraining of design managers and design staff · use of consultants · evaluation of the design process · product evaluation, including third party product certification and approvals ·…   Read more»

Validation may not be necessary for all the reasons listed above but it’s still better to perform them as it keeps the team and the design on one page. If something changes then it can definitely be verified in the…   Read more»

I haven’t really had experience dealing with DHF documents but in the past we have kept all our important documents in SharePoint and that has been very helpful. It provided us a place to upload and make the latest documents…   Read more»

If I am running a company, I would prefer to outsource the design transfer to lower the labor costs, real estates and plant costs, fewer regulations and much more. With that, as a precaution, I would also first send a…   Read more»

I don’t think it is necessary although, having clinical background would certainly help. Every place that hires a new employee will go through the training and that should cover up whatever they are expected to do. Therefore, it is not…   Read more»

I 100% believe clinical studies are important but in my experience, I have learned that a lot of mistakes happen. Either it is human study or animal study. Frankly, animal study more often than human, may be because no animal…   Read more»