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ri62
@ri62
Trusted Member
Joined: Jan 23, 2025
Last seen: Sep 28, 2025
Topics: 0 / Replies: 51
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RE: Does the FDA guarantee safety?

In medical device development, the FDA does not fully guarantee safety but rather ensures that devices meet established standards of safety and effect...

3 days ago
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RE: Are Regulations Helping Innovation or Slowing It Down?

Regulations in medical device development are designed to protect patient safety and ensure product effectiveness, but their impact on innovation is o...

3 days ago
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RE: Who Should Be Responsible for Regulatory Basics?

In medical device development, regulatory basics should primarily be the responsibility of the regulatory affairs team, as they are trained to interpr...

3 days ago
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RE: Ethics of Animal Testing

Animal testing in medical device development raises important ethical considerations. Researchers must balance the potential benefits to human health ...

2 weeks ago
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RE: Ensuring Biocompatibility in Medical Devices

Ensuring biocompatibility in medical device development is essential to confirm that devices interact safely with the human body without causing adver...

2 weeks ago
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RE: Animal Diversity in Pre-clinical Research

Animal diversity in pre-clinical research for medical device development is critical to ensure safety and efficacy before human trials. Different anim...

2 weeks ago
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RE: Managing Team Opinions While Sticking to Decisions

Managing team opinions while sticking to decisions is a crucial skill in medical device development. A project manager must listen carefully to input ...

3 weeks ago
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RE: Manager Vs Engineering

In medical device development, managers and engineers play different but complementary roles. Engineers focus on the technical aspects, such as design...

3 weeks ago
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RE: Which feature is the most important for a project manager?

One of the most important features for a project manager in medical device development is strong leadership. A project manager must be able to guide a...

3 weeks ago
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RE: Medical Device Certification

Medical device certification is a critical step in the development process to ensure safety, quality, and effectiveness. It involves meeting regulator...

3 weeks ago
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RE: Is AI going to control the medical Industry ?

AI is transforming healthcare, but it cannot fully control the medical industry. Human expertise, judgment, and empathy remain essential in diagnosing...

3 weeks ago
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RE: Medical Device News

Medical device news plays a vital role in the development of new medical technologies. It keeps researchers and developers informed about the latest i...

3 weeks ago
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RE: Optimizing Clinical Trials Using Technology

Optimizing clinical trials using technology is crucial for accelerating medical device development. Electronic data capture (EDC) systems streamline d...

5 months ago
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RE: How small projects can grow out of control without warning

Small projects in medical device development can grow out of control without warning if risks are not properly managed. Scope creep often occurs when ...

5 months ago
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RE: Early Risk Management in a Project

Early risk management in a project is critical for the successful development of medical devices. Identifying potential risks at the planning stage al...

5 months ago
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