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Torikul
@torikul
Trusted Member
Joined: Jan 17, 2024
Last seen: Dec 1, 2024
Topics: 9 / Replies: 67
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RE: Factors to consider when executing the NDA

i agree with others and i think that company decides how much information to disclose in an NDA by assessing the nature of the collaboration, tthe sen...

3 months ago
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RE: Legal Agreements in Effective Collaboration

I think that when drafting agreements in the medical device sector, clarity and mutual understanding are crucial to balance cooperation and protection...

3 months ago
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RE: Confidentiality and Transparency in Consulting Agreements

I think that to effectively balance confidentiality and transparency when hiring consultants, companies should establish robust Non-Disclosure Agreeme...

3 months ago
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RE: Group Projects: Organizational Types

I agree with others. People may have different option's. however i believe that a matrix organization structure would benefit our group and device dev...

3 months ago
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RE: AI & IoT in medical device industries.

I think organizational development plays a pivotal role in helping medical device companies integrate advanced technologies like AI and IoT. It foster...

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

I agree with others. I believe that medical device companies can adopt several organizational development strategies to align with value-based healthc...

3 months ago
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RE: Risk Management: Risk v.s. Reward

I think many biotechnology companies prioritize rewards, especially when potential breakthroughs promise significant financial and clinical impact, bu...

3 months ago
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RE: Risk Management Tools

I have used FMEA and Fish Bone Diagrams in past projects to identify and analyze potential risks systematically. FMEA is my preferred tool because it ...

3 months ago
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RE: Residual risk during device development

i believe that determining the acceptable level of residual risk requires clear criteria aligned with ISO 14971 and patient safety expectations. A ris...

3 months ago
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RE: Validation Study Success Defined

I agree with others. I believe that to define success criteria, a team first engages stakeholders to understand their needs and expectations. They set...

4 months ago
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RE: The Relationship Between Verification and Validation

Verification ensures a product meets its design specifications, while validation ensures it meets user needs. These processes can be conducted simulta...

4 months ago
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RE: Impact of customer feedback on design inputs

I think design teams prioritize customer feedback by identifying common themes across various sources. They segment customers into distinct user perso...

4 months ago
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RE: Benefits of Software Validation

I agree with others comments. I believe that two additional long-term benefits of software validation that positively impact a device with software ov...

4 months ago
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RE: The Defines of Design Controls

I agree with you. I believe that design controls are essential quality practices applied in the medical device design and development process to ensur...

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

To manage a large DHF effectively, break it down into modular sections aligned with design phases and use a detailed, hyperlinked table of contents. M...

4 months ago
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