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Mirna Cheikhali
@mirna-cheikhali
Trusted Member
Joined: Sep 5, 2024
Last seen: May 5, 2025
Topics: 2 / Replies: 49
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RE: Design Verification Failures

In this week's simulation, we were given a failed design verification test and tasked with redesigning the test to find out why it failed and how to f...

7 months ago
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RE: The Role of Regulatory Strategy in Combination Product Development

Having an in-house regulatory team is really important, especially for companies with a lot of complex combination products. They know the company’s p...

7 months ago
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RE: Role of Project Management in Medical Device Development

Although I don’t have direct experience in managing medical device projects, I can imagine it’s quite a complex process. The combination of strict reg...

7 months ago
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RE: Pre-market Approval (PMA) vs. 510(k)

The FDA approves medical devices through two main pathways: PMA for high-risk Class III devices, requiring extensive clinical testing, and 510(k) for ...

7 months ago
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RE: Handling Conflicts Among Team Members Effectively

Although I don't have direct experience working as a Project Manager, these are some things I have learned through my courses. Conflicts over opinions...

8 months ago
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RE: Balancing time, cost and scope in project management

Although I don’t have direct experience managing medical device projects, my background in chemical engineering and biomedical engineering studies hav...

8 months ago
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RE: Legal Agreements in Effective Collaboration

When it comes to agreements, one of the most important things is making sure everyone knows what’s expected from the start. For example, in consulting...

10 months ago
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RE: Company Insurance

Having a solid plan in place for emergencies is definitely a smart move. If something happened to me, I’d want a clear roadmap for how things should b...

10 months ago
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RE: Confidentiality and Transparency in Consulting Agreements

To strike a good balance between protecting sensitive information and being transparent when working with consultants, companies need a thoughtful app...

10 months ago
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RE: Risk Management in the Manufacturing Process

In manufacturing, risk management is all about catching potential issues early to keep things running smoothly and safely. While avoiding risks is a b...

10 months ago
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RE: Risk Free Analysis

A key but often overlooked part of risk management in medical devices is human factors engineering (HFE). While frameworks like ISO 14971 help address...

10 months ago
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RE: Residual risk during device development

When developing medical devices, figuring out what level of risk is acceptable comes down to balancing patient safety, technology, and costs. It invol...

10 months ago
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RE: Details needed in a DHF for complex devices

Managing a big, complex Design History File (DHF) can definitely be tricky, but one good way to handle it is by keeping things organized. Breaking it ...

10 months ago
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RE: Effective Use of Design Transfer in Streamlining Production for Medical Devices

Design Transfer is a key part of moving from development to manufacturing, and there are a few ways companies can improve it to avoid production issue...

10 months ago
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