Continuing from alexandrabuga’s response, a Request for Designation is a written to the Office of Combination Products (OCP) requesting regulatory classification to determine if it is a device, drug, and/or biologic product and which Agency will be assigned. The FDA formally responds to RFD’s by returning a letter of designation. The letter of…[Read more]

I agree with your ideal skills, having a team that varies in their experience and background, works well together, and has a passion and drive in their efforts as a valuable team member. Reliability, involvement, determination, and the ability to self manage are individual qualities that each member needs to have. Social skills plays a very…[Read more]

I believe this is a very good conversation in understanding that different cultures can be seen in project management. What I have understood from experience of myself and friends is that management plays a very critical role in the companies environment and strategy. Relating to what I have currently seen in the medical industry in comparison to…[Read more]

In response to the experience seen in industry, I have similar input as hruship101 and srg36. Working for a global SMBG company, validation and verification (V&V) is understood to be our leading factor in producing products of high quality. Accuracy, durability, reliability, and consistency are very critical aspects in providing persons with…[Read more]