Forum

ma2726
@ma2726
Trusted Member
Joined: Jan 18, 2024
Last seen: Nov 6, 2024
Topics: 12 / Replies: 55
Reply
RE: Details needed in a DHF for complex devices

When designing a DHF for complicated devices, it is crucial to prioritize clarity and accessibility, especially for regulatory reviewers who want quic...

2 days ago
Reply
RE: Understanding Design Controls and Documentation in Medical Device Development

Under FDA's 21 CFR Part 820.30 Design Controls offer a methodical approach to guarantee that medical equipment is built with safety and regulatory com...

2 days ago
Reply
RE: Validation's Role in Quality Product Development: Insights and Challenges?

Using a risk-based strategy that is customized for every phase of the product lifecycle is another essential component of validation. By concentrating...

2 weeks ago
Reply
RE: Validation Study Success Defined

You make some really good comments about basing success criteria with historical data and frequent evaluations. Incorporating user-centered design inp...

2 weeks ago
Reply
RE: The Defines of Design Controls

You give a concise overview of design controls and how they help guarantee device safety and FDA compliance. Building on this, the strategic influence...

2 weeks ago
Reply
RE: Clinical Trial Participation

Both of your points highlight the diverse motivations for participating in clinical trials, from access to innovative treatments to contributing to me...

3 weeks ago
Topic
Replies: 5
Views: 28
Reply
RE: What is not seen in Clinical Trials?

While clinical trials provide valuable data, they often miss important issues that only emerge through post-market research. For example, long-term si...

3 weeks ago
Reply
RE: Is entering a career in sales worth it?

Engineers can leverage their technical expertise in customer-facing contexts through sales and marketing roles in the medical device business. These p...

3 weeks ago
Reply
RE: Company Mission Statement

If I were starting my own business, I would specialize on designing cutting-edge biorobotic prosthesis for people with mobility problems. My company w...

3 weeks ago
Reply
RE: marketing strategies and technology

I agree with both participants that medical device marketing techniques must adapt, especially with technology and engineering. Building on this, the ...

3 weeks ago
Reply
RE: Non for profits

While it's clear that nonprofit organizations focus on public benefit, and the cost structure for a medical device or pharmaceutical company presents ...

1 month ago
Forum
Topic
Forum
Replies: 2
Views: 20
Reply
RE: A sole proprietorship a corporation...?

Interesting points, everyone. While I agree that a sole proprietorship isn’t a corporation, it’s crucial to highlight that the key difference stems fr...

1 month ago
Forum
Page 1 / 5