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mjc22
@mjc22
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Joined: Sep 4, 2024
Last seen: Mar 16, 2025
Topics: 0 / Replies: 58
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RE: Functional vs Project-Based vs Matrix Organizations – Which Works Best?

Balancing structure and flexibility in medical device development requires developing an approach that fits organizational structure with project need...

2 months ago
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RE: Misclassification of a Device?

Filing for FDA approval of a misclassified device can cause major hinderances to the entire process, whether the company filed a class II device as cl...

2 months ago
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RE: Critical Role of Design Controls in Medical Device Projects

Organizations can find a balance between regulatory compliance and innovation without compromising agility by practicing open communication, involving...

2 months ago
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RE: Transitioning to New Technologies During an Ongoing Project

When considering using new technology in a project, the PM must take into consideration the impact to the overall cost and timeline of the project. If...

2 months ago
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RE: Importance of Regulatory Strategy in Medical Device Project Management

A strong regulatory strategy is essential for effective project management in the medical device industry, as it reduces risks such as costly delays, ...

2 months ago
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RE: Balancing Innovation with Compliance

The biggest regulatory challenge in developing emerging medical technologies involving AI or machine learning is finding a balance between adhering to...

2 months ago
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RE: Project Success and Scope Creep

A project manager can keep project goals dynamic while avoiding scope creep and ensuring successful delivery by establishing a strong framework for co...

2 months ago
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RE: How to communicate effectively between team mates in project team ?

When it comes to working within a team virtually, I find that the best way to effectively communicate is finding the right platform and giving everyon...

2 months ago
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RE: Remote or In-Person PM

In my opinion, a balanced combination of in-person and virtual communication can be used in successful project management. I do not think it necessary...

2 months ago
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RE: Verbal Contracts

Verbal contracts are much less common than written contracts in the medical device industry, but they can be important in situations where an immediat...

4 months ago
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RE: Value-based healthcare: "Dos and Don'ts"

To keep up with the shift toward value-based healthcare, medical device companies should prioritize patient outcomes, operational efficiency, and work...

4 months ago
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RE: Ways to deal with risks

Risk management is extremely important to the medical device sector. Here are a few examples of each of the 4 strategies discussed in the lecture rela...

5 months ago
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RE: Residual risk during device development

There are ISO and FDA standards that frame how risk management should be handled when it comes to medical devices. According to ISO 14971, risk analys...

5 months ago
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RE: Different Standards for Design Controls

When companies interpret standards like ISO 13485 and 21 CFR 820.30, several factors influence their approach. These interpretations show the balance ...

5 months ago
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RE: The Relationship Between Verification and Validation

Verification and validation each have their own distinct purposes. Verification ensures that a design meets specific technical requirements and valida...

5 months ago
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