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cp527
@cp527
Active Member
Joined: Jan 30, 2023
Last seen: Dec 3, 2023
Topics: 0 / Replies: 19
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RE: Matrix Strength

The choice of matrix type is not strictly dependent on the nature of the medical device but on various factors: Project Complexity: Complex medi...

1 year ago
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RE: Verbal Contracts

It's important to note that the enforceability of verbal contracts varies by jurisdiction, and some contracts may be required to be in writing to be e...

1 year ago
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RE: Advamed Guidelines

In the context of sponsored events and hospitality, the term "reasonable location" is generally subjective and may vary based on industry norms, ethic...

1 year ago
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RE: When is giving gifts like the "old days" too much?

In the corporate world, gift-giving is often subject to ethical considerations, legal regulations, and company policies to ensure transparency, fairne...

1 year ago
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RE: US FDA vs EU MDR Risk management

ISO 13485 and ISO 14971 serve distinct purposes within the context of medical devices, and their relationship is not necessarily a reflection of insuf...

1 year ago
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RE: SWOT analysis for risk management

A SWOT analysis for the proposed project involving a lithium pump for sensing glutamate levels in the brain after traumatic brain injury: Strengths:...

1 year ago
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RE: Design Input Requirement Categories

Certainly! Let's consider an example of each requirement category for a medical device: Functional Requirement: Example: For a medical infus...

1 year ago
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RE: Document Corrections

In the context of document control and management, when errors or changes are identified in documents like Device Master Record (DMR) or Device Histor...

1 year ago
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RE: Benefits of Software Validation

Two other benefits that positively impact a device with software over its life cycle are: Improved User Satisfaction: Proper software validation...

1 year ago
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RE: Placebo Effect

The placebo effect is a well-documented and intriguing phenomenon in clinical trials. It can be challenging to differentiate the placebo effect from t...

1 year ago
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RE: Diversity and Inclusion in Clinical Trials

Ensuring that clinical trial patient groups are representative and do not underrepresent groups affected by the health condition being studied is crit...

1 year ago
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RE: What if I told you...

The scenario you describe raises several important ethical and regulatory considerations. Efficacy: If a drug is found to cure the common cold o...

1 year ago
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RE: Ethics of Corporation considered as an entity

The question of whether corporations should be considered moral entities, thereby receiving blame or praise instead of the people running them, is a c...

1 year ago
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RE: LLP vs LLC

Choosing between a Limited Liability Company (LLC) and a Limited Liability Partnership (LLP) depends on the specific needs and goals of the business, ...

1 year ago
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RE: Business Courses for Engineering Students?

I believe that, the question of whether engineering students should be required to take an additional business course or participate in workshops to e...

1 year ago
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