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reshamn
@reshamn
Trusted Member
Joined: Sep 8, 2017
Topics: 3 / Replies: 64
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RE: Forming a Project Team

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 ...

7 years ago
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RE: Matrix Organization- Conflict

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 a...

7 years ago
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RE: Upper vs Middle Management.

Delegation is one of the key differences between upper and middle management. Since a senior manager spends most of his energy on creating effective s...

7 years ago
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RE: Deviations That Occurs During Verification

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....

7 years ago
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RE: Statistical Sampling

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

7 years ago
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RE: Design Review Meetings

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 o...

7 years ago
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RE: a successful validation process

A successful validation program brings together engineering, manufacturing, regulatory compliance, and quality assurance to develop test solutions tha...

7 years ago
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RE: Why VERIFICATION is important? and Your ideas to improve Verification process ?

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 qualit...

7 years ago
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RE: Verification Protocol

Multiligamentous Ankle Supports (L1906) A multiligamentous ankle support provides control of the ankle joint between the medial and lateral malleoli ...

7 years ago
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RE: Factors to Consider While making Gantt Chart

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, conside...

7 years ago
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RE: How to ensure your DHF is audit ready ?

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 ac...

7 years ago
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RE: What FDA Looks For In A Design Control System ?

Defining user needs are extremely important as in the future you definitely need to demonstrate that the product you develop addresses the User Needs ...

7 years ago
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RE: Clinical Studies

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 th...

7 years ago
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RE: Clinical Trial Roles

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 co...

7 years ago
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RE: Discussion Topic: Having a "clinical background"

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 ama...

7 years ago
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