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
· patenting or other means of design protection

Source:
(2017). Fda.gov. Retrieved 13 Novem…[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 clinical trials which can be beneficial to the organization. Nowadays people trust the organizations more who have accurate data and I…[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 available to rest of the group. I think if DHF document is maintained by the project manager then it would be up-to-date…[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 small batch to be produced and make sure it meets the company standards.

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 necessary to have clinical background at all.

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 can sue. But that’s sad and disheartening. Biggest disadvantage is losing a life whether it is human or animal. In one of…[Read more]

Well as of today consent is most important thing in medical field. Whether we like it or not, approve it or not, it will be there and i feel it is definitely not going anywhere. I am very much behind signing consent forms from any patients or any donor as a matter of fact. It will be solely their and only their decision whether to say yes or not.…[Read more]

I am going to take over here the example of cars. I really liked the advertisement on TV of Chevvy’s. Customers are basically asked to drive an unknown car or just sit and feel the car or check out the exterior of it. This way they don’t judge the book by it’s cover. I have also seen this done by the local car dealership in my area. Where customer…[Read more]

One another way a company can showcase the medical device is via a video demonstration. Along with conferences and summits, companies can make these videos available on social media websites. There has been countless number of times where I have seen new surgical device demonstration on FaceBook. Also, it is vital to create the buzz in the…[Read more]

The link did not work But i could found the video on youtube. This video is hilarious but of course little exaggerated. Anyway, I have had not much of an interaction with the clients similar to like this. But I have faced the situation where client wants data in 10 business days which is literally not possible due to expired stocks or not enough…[Read more]

If I am the only owner, I would prefer to register an LLC because of low risk and less hassle of the taxes. If the company is product based, and needs more time to focus on production or manufacture than saving time in receiving a loan can benefit the company as one less thing to worry about. This also means more focus on customer and their…[Read more]

I would not prefer getting into a partnership because even when the ideologies are the same, the execution will always be different. Being in a partnership does offer low risk and support but views do change from time to time and getting to a conclusion only gets difficult in the future. Everyone works at a different pace and both the partners…[Read more]

This is my third position, and not have I ever looked up the type of company it is. I dont think personally it matters to me because what matters is the position and what kind of work I am going to do. Job description is certainly more important for me than the type of company.

Document control will be easier for QA and R&D department if documents that need to be filled out, are entered without any error or miss information or mainly without any false information. Working on research and documenting at the same time, is the hardest part of the job since scientist have to be accurate about both. Therefore, mistakes are…[Read more]

I work in R&D department, I haven’t had any issues with QA/QC department. I have worked as a QA before and I did not experience issues with the developer team. Everything I reported was resolved on time. At my current job, I have seen things go down south and it was primarily because there is a bit of a lag from their team. I personally think if…[Read more]

Considering ‘quality is a burden’ is one of the most common mistake of people. Most of the time people in R&D wants product to get qualify and out of the door ASAP. Which makes sense, since they have worked absolutely hard to get the finished product. But still this does not mean that it is perfect product and does not need any quality check. If…[Read more]

I think if every department follows rules and regulations then there should not be any conflict. ALthough, this is not possible in real world because there will be something or other that will go wrong either in data or device or just in documentations. The way for departments to work together and calmly accept the fault and make sure it does not…[Read more]

I don’t think FDA is too strict in approval the medical device or drugs. There are way too many side effects later in life which might not be visible at the time of the inventions. Checking every meticulous detail, and putting together all the pros and cons, and making decision is hardest thing ever. If something goes wrong, FDA will be the one to…[Read more]

Accuracy and precision play important role when it comes to FDA and their rules and regulations. I think they main reason they are important is to make sure any medical device is consistent and there is no adverse effect on the patient. Any medical device needs to pass through accuracy and precision or else it cannot pass the validation of that…[Read more]