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Forum Replies Created

NDA vs Patents

As learned this week, it is important to protect our ideas and inventions and to do so in the appropriate legal manner. Part of the lesson discussed Non-disclosure agreements, or contracts, and how th...

In forum Consultants and Legal Basics

8 years ago
RE: Written Agreement v/s Verbal Agreement

There can be some confusion with the use of the word "verbal". A verbal contract can include any agreement with words, which includes both oral and written agreements. Therefore, it's best to compare ...

In forum Consultants and Legal Basics

8 years ago
RE: Discussion Topic: Course conclusion and impressions

I feel like the only course in undergrad that introduced industry-related topics was capstone, since it involved working on a project from start to finish and all its deliverables. However, since this...

In forum Consultants and Legal Basics

8 years ago
RE: Organization types of medical devices?

If I was to start a company that worked on a world-scale, the worst thing to form is an organic structured organization, in my opinion. A company working globally needs to have a rigid structure so ev...

In forum Organizational Development in Device Companies

8 years ago
Forming a Project Team

As we know, forming a project team is partly making sure every member is working toward the same goal(s). Each member should be able to contribute something valuable to the project according to their ...

In forum Organizational Development in Device Companies

8 years ago
RE: Discussion Topic: Your organizational type

In my company, I work in a project-based/matrix-based combination of an organization. There are multiple projects going on at a time and each project has it's team. However, the teams are made up of s...

In forum Organizational Development in Device Companies

8 years ago
RE: Risk Management Mistakes

In my opinion, I think a major mistake would be to assume that one is only looking for extreme and catastrophic risks and therefore overlooking risks that are also important. For example, there are ri...

In forum Risk Analysis for Medical Devices

8 years ago
RE: Factors Contributing to Risk Values

It is important to distinguish the types of risks you are analyzing. For example, there are risks that impact business, those that impact manufacturing, and the obvious risks with the device itself. A...

In forum Risk Analysis for Medical Devices

8 years ago
RE: Risk management and Labels

I agree - There comes a point where the company has done their part by putting warnings on labels and the customer who is using the device is responsible for following those instructions. For that to ...

In forum Risk Analysis for Medical Devices

8 years ago
RE: Design input sources

Deepthi, yes it is a common practice to keep these inputs and specs in an excel spreadsheet as part of the Design Requirements Matrix (DRM). This document may even be a live document that can only be ...

In forum Introduction to Design Controls

8 years ago
RE: Making up tests for design verification and validation

As we have learned and many have already mentioned, verification tests come about from the design specifications in the DSD. Each specification can have a test linked to it and will be explored durin...

In forum Introduction to Design Controls

8 years ago
RE: Factors to Consider While making Gantt Chart

I've realized several things about Gantt charts in the industry. The plan laid out by Gantt chart should be followed as close as possible, especially since projects have deadlines to be met. However, ...

In forum Introduction to Design Controls

8 years ago
RE: Design Verification & Validation

There are major differences between design verification and design validation. For one thing, validation always occurs after verification, and in some case may not be required at all. Verification tes...

In forum Introduction to Design Controls

8 years ago
RE: Design input sources

When developing an inputs document for a new product it may be a challenge to obtain or come up with the inputs and specifications. As mentioned in the lecture, R&D engineers may help support this...

In forum Introduction to Design Controls

8 years ago
RE: Discussion Topic: Supplemental on DHF and DMR

I agree that there exists an advantage to have the entire design process documented in a DHF versus a snapshot of the design process with the Design Dossier or Tech File. For one thing, we are able to...

In forum Introduction to Design Controls

8 years ago