To create a verification test for a medical device system, there are several steps that can be taken to help ensure that it passes: Identify the...

I agree with your concerns regarding the potential risks associated with this combination product. The fact that it is both a device and a drug and co...

@sanam I couldn't agree more with your perspective on investing in a project. It is indeed crucial to have a clear understanding of the target market...

@gingeranderson I completely agree with your views on the composition of an ideal team. Having a technical expert with formal education is indeed esse...

I believe that the most crucial ability a project manager should have is communication. A team is required to develop a product; one person cannot acc...

A smaller team environment is what I would desire. I frequently discover that work can be distributed unfairly in larger teams, causing some people to...

I believe that interpersonal skills in general are just as important as technical skills. Nobody, in my opinion, is able to accomplish everything by t...

The basic objective in developing a commercial product is to have it available in the primary market first and then extend into other countries. Appro...

The FDA Design Controls must be followed during the bulk of medical device development. The FDA uses design control to certify the efficacy and safety...

Communication is the way to finding true success in the clinical device industry. Another significant expertise would be coordinated effort. This is v...

With a significant emphasis on the needs of the end user, design inputs make sure that your design requirements match up with the planned use of the p...

I wanted to expand a little on the comment made about how tough it may be for the buying department to find and approve new vendors because this can b...

I have to agree with you that a lot of smaller businesses hire separate companies to be able to manufacture their device because it is cost-effective ...

The entire product design and delivery depend on each step in the design control process. I'd like to assume that design verification is the most sign...

Design controls, in my opinion, ought to be taken into account when determining if a product in development is commercially viable. Customers and stak...