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sah67
@sah67
Trusted Member
Joined: Jan 16, 2023
Last seen: Dec 11, 2023
Topics: 0 / Replies: 78
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RE: NDA vs Patents

Hello,NDAs and patents serve distinct purposes, and while they can complement each other, they are not substitutes. An NDA is a legal contract between...

1 year ago
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RE: Written Agreement v/s Verbal Agreement

Hello,The distinction between "verbal agreement" and "oral agreement" is often subtle, and the terms are used interchangeably in many contexts. Both r...

1 year ago
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RE: Restrictions for physician's gifts

Hello, Your observation raises a valid point about the restrictions on gifts and expenses in the context of collaborations between companies and phy...

1 year ago
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RE: Organization Type vs. Effectiveness

Hello, There is no one-size-fits-all answer to the question of the best organizational structure, as the effectiveness of a particular structure dep...

1 year ago
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RE: Upper vs Middle Management.

Hello, Personally, I believe my skills and talents align well with both Upper Management and Middle Management roles. Recognizing the value of leade...

1 year ago
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RE: Forming a Project Team

Hello, When forming a project team, it is crucial to strike a balance between interpersonal relationships and expertise within the team. While havin...

1 year ago
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RE: What is Risk-benefit analysis ?

Hello, One key factor outlined by the FDA in the risk-benefit analysis for decision-making regarding product availability, compliance, and enforceme...

1 year ago
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RE: Risk Identification

Hello, While I don't have personal industry experience, I can share common practices in risk identification and prioritization. In many companies, t...

1 year ago
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RE: Risk Management Mistakes

Hello, The points highlighted in the article represent critical aspects of risk management in the context of medical device development, and they al...

1 year ago
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RE: Validation vs Verification

Hello, While I don't have personal industry experience, I can provide insight into the conceptual difference between validation and verification. Th...

1 year ago
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RE: Design Review Meetings: Attendance & Causes for Scheduling

Hello, In addition to the project leader, design review meetings should ideally include key personnel representing various aspects of the product de...

1 year ago
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RE: Gantt Chart Thought Process and Considerations

Hello, Creating a Gantt chart is an important step in project management. When organizing tasks, start by identifying the project's major milestones...

1 year ago
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RE: Consequences Of Insufficient Design Controls

Hello, When Design Control is used insufficiently or not adhered to properly in the development of medical devices, several significant issues can a...

1 year ago
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RE: What are Design Controls?

Hello, Design Controls, as defined by the FDA in 21 CFR 820.30, are a crucial component of the regulatory framework for medical device development. ...

1 year ago
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RE: Minutes for meetings

Hello,It's great that you've started to recognize the significance of taking minutes in team meetings. Meeting minutes might appear as a routine admin...

1 year ago
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