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Dev Doshi
@dev-doshi
Trusted Member
Joined: Sep 5, 2025
Last seen: May 5, 2026
Topics: 8 / Replies: 67
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RE: Project Management Software

I think the optimal project management software should have intelligent automation and predictive analytics that all members of the team can use to se...

3 months ago
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RE: Project Management and Design Controls

I agree with how separating design controls and management can lead to issues with verification and validation. I think rushing these processes takes ...

3 months ago
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RE: Project Managers utilization of PDCA and other structured processes

  I think design reviews and design changes are most important during the Check and Act phases of the PDCA cycle. The Check phase is important ...

3 months ago
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RE: A More Integrated Approach to Project Management

One way to reduce “project myopia” is to connect the project lifecycle to the higher-ups at multiple points in the timeline. This ensures that the pro...

3 months ago
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RE: issues with bottle label

You bring up good points about the submersion and drying times of the bottle label, since the timing is important for adhesion and how strong the adhe...

3 months ago
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RE: Challenges in Managing Medical Device Projects

The key theme across all these responses is that challenges in the regulatory section of project management must be addressed pre-emptively. Any issue...

3 months ago
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RE: PM's Role Addressing Challenges in Device Approval Pathways

I think you make a good point about planning for uncertainty, since it is almost never possible for a best-case timeline for sure. This is especially ...

3 months ago
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RE: Medical Device Project Start-up

  I currently work in a neuroscience lab that deals with the Protecadherin gene in the brain. This gene codes for the “molecular barcode” of ea...

3 months ago
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RE: PERT and CPM as managerial techniques in the Medical Devices Industry

I myself have not worked in industry yet, but I asked some family members who do about your question. PERT and CPM are used more implicitly in practic...

3 months ago
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RE: Maintaining the licenses for manufactures

I like how it is very clear that continuous compliance is the main point regarding FDA “licensure.” From the standpoint of project management, this mo...

3 months ago
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RE: Distinguishing Between Hazards and Hazardous Situations in Risk Evaluation

I think everyone here did a good job at breaking down the conceptual difference between hazards and hazardous situations. Something new I have to add ...

6 months ago
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RE: Getting Everyone's Input in Risk Management Meetings

I like how everyone emphasized how important structure, preparation, and inclusion is in risk management meetings. I want to talk more about the forma...

6 months ago
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RE: Poka-Yoke/ Error Proofing

Everyone has brought up excellent points about Poka-Yoke and how it reduces errors on the production floor. However, something that no one has touched...

6 months ago
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RE: Efficiency or Compliance?

I agree that design controls are more than a regulatory requirement in the sense that they are frameworks for quality and long-term communication. To ...

6 months ago
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RE: Process Validation for OEMs

I think everyone made great points regarding documentation, calibration, and clear communication between the Original Equipment Manufacturers and the ...

6 months ago
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