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Michael_Patel
@michael_patel
Eminent Member
Joined: Sep 8, 2024
Last seen: Dec 1, 2024
Topics: 0 / Replies: 28
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RE: Written Agreement v/s Verbal Agreement

Hi kbs27,In my past, I once had a verbal contract go bad, leading to a messy lawsuit because key details weren’t documented. I wont get into the detai...

2 months ago
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RE: Advamed Guidelines

Hi jj52,An unreasonable location for a sponsored event might include luxury resorts or exotic destinations that primarily promote leisure rather than ...

2 months ago
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RE: Advice before signing an NDA

Hi merzkrashed,If you are ever in the situation, when signing NDA, carefully review its terms to ensure clarity and fairness. Ensure that the scope of...

2 months ago
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RE: Expense of Regulations

Hi sdl3,I feel as if regulations likely cost money because they are developed by organizations that invest significant resources in research and maint...

2 months ago
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RE: To risk manage or not to risk manage?

Hi rajamharrison,It goes without saying that risk management is absolutely an essential part of the planning phase. Identifying potential risks early ...

2 months ago
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RE: Risk Management Tools

Hi traceymraw,In the past for projects at work, I’ve used brainstorming and the Fishbone Diagram for identifying and organizing potential risks in pro...

2 months ago
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RE: Feeling Safer?

Hi elm33,Yes after this week's lecture and learning about validation and verification processes I do feel safer using medical devices. We learned that...

2 months ago
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RE: Design Verification Ethics

Hi cem34,It goes without saying that neglecting to record unsuccessful instances during design verification in the name of saving time is a serious et...

2 months ago
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RE: Benefits of Software Validation

Hey jbh8,In addition to decreased failure rates and fewer recalls, software validation improves user trust and satisfaction. This is because validated...

2 months ago
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RE: Consequences Of Insufficient Design Controls

Hi la82,You are right design control is an integral part of product development, but issues can arise if it’s poorly managed. Without proper design co...

3 months ago
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RE: Design control and risk management

Hi sumayia-chowdhury,Design control teams mitigates risk by implementing a structured, step-by-step process throughout the development of a product. B...

3 months ago
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RE: Design Output

Hi hodafattel,You are right in saying that inputs usually have outputs, but not always directly. For instance, a DID might specify user needs like "ea...

3 months ago
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RE: What is not seen in Clinical Trials?

Hi sn64,Clinical trials may miss long-term side effects, rare adverse reactions, and interactions with other medications due to limited sample size an...

3 months ago
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RE: Double Blind Vs Single blind Study

Hi smitshah,Double-blind studies are critical because they prevent both patient and investigator biases which can affect the study outcomes. If the in...

3 months ago
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RE: WHAT IS THE OBJECTIVE OF CLINICAL TESTING ON PHARMACEUTICA DRUGS?

Hi amd29,I feel as if clinical testing of pharmaceutical drugs is ESSENTIAL to assess their safety, efficacy, and potential side effects. Unlike medic...

3 months ago
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