Although, the team members enjoy working with people who they have a good rapport with. However, in my experience roles are allocated in a team based on a team member's expertise and background. There...

I too have been a part of a Matrix organization. I would agree with the posts above that it does get confusing sometimes. I had a functional manager and a reporting manager for the same project. Howev...

Delegation is one of the key differences between upper and middle management. Since a senior manager spends most of his energy on creating effective strategies. He has to be able to delegate decision ...

Software can be an essential component of the medical device, whether it is designing a new product or improving the functionality of an existing one. When it comes to the software in medical devices,...

There are several factors that must be considered when determining the appropriate sample size including risks associated with the product, costs associated with producing the product, and costs assoc...

Feedback plays a critical role in the design process. In order to make sure the review meetings go smoothly, the attitude of the team needs to be in order. The meetings should not devolve into firing ...

A successful validation program brings together engineering, manufacturing, regulatory compliance, and quality assurance to develop test solutions that are unique to each application. Developers of me...

Adding to the previous posts, the format of the Design Verification is equally important. Although, format of the DV is not as important as the quality of information it contains. However, if the data...

Multiligamentous Ankle Supports (L1906) A multiligamentous ankle support provides control of the ankle joint between the medial and lateral malleoli while allowing for dorsiflexion and plantar flexion...

An important tip in creating a Gantt Chart is defining a critical path. It is a method of looking at all of the activities in the Gantt chart, considering the timing and dependent relationships of eac...

One thing to point out about a DHF is that every team member who is involved in the planning/development of a particular medical device should have access to the DHF. Sometimes, new recruits might not...

Defining user needs are extremely important as in the future you definitely need to demonstrate that the product you develop addresses the User Needs you define. FDA doesn’t really define User Needs i...

The most obvious advantage of a clinical trial is that you have access to a new treatment that you wouldn't have otherwise. People are likely to go through regular testing which is in most cases very ...

I would opt for the Clinical Quality Assurance Auditor (CQA). CQA inspects the documents and processes of the clinical trial to make sure that they comply with certain guidelines, known as the good cl...

From a little bit of research, it seems very apparent that prior experience is required for applying for a role in clinical research. I agree with amandaally1029 thoughts that it varies for different ...