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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...

12 months 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...

12 months 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...

12 months 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...

12 months 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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