su65

Forum Replies Created

RE: Restrictions for physician's gifts

I think the rules set are good. Because, physician can attend business meeting but I dont think wife has anythig to do with that business meeting. We should not let money take over and hence it is goo...

In forum Consultants and Legal Basics

7 years ago
RE: NDA vs Patents

NDA is a contract between two people who agree not to disclose anything related to product and sign. A patent is a document which shows/proves the ownership of the idea. That is the idea is patented b...

In forum Consultants and Legal Basics

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

Oral agreement is limited to words spoken by people. There is no evidence unlike in written agreement. Oral agreements are difficult to defend in court unless there is a proper evidence. Written agree...

In forum Consultants and Legal Basics

7 years ago
RE: Organization types of medical devices?

I would consider choosing matrix organization for my company. Matrix organization has given successful results in managing the project. It gives better allotment of resources. There will be knowledge ...

In forum Organizational Development in Device Companies

7 years ago
RE: Matrix Organization- Conflict

I think I have the technical expertise to run a project as a middle-level project manager. Also, I agree with other that, to negotiate with clients and plan/developing Strategies, one must gain enough...

In forum Organizational Development in Device Companies

7 years ago
RE: Effective way to culminate inter department silos

I agree with akshayakirithy and srg36. Making departments understand and work together, it is very important to bridge the gap or clear the differences between them. interdepartmental team building ev...

In forum Organizational Development in Device Companies

7 years ago
RE: Risk Management Mistakes

It is always good to have wide variety of inputs from people at all steps of product process to analyse and identify risks because its difficult to know when and how a risk can occur. Even after the p...

In forum Risk Analysis for Medical Devices

7 years ago
RE: Risk management and Labels

Labelling and istructions are very important for a medical device. Its the way to tell users to how to use device. Companies while advertising the product can actually show how to use the product and ...

In forum Risk Analysis for Medical Devices

7 years ago
RE: Manage Risk

High severity risks are unacceptable because they can cause severe harm to patients. Avoidance or mitigation would be good for high severity risks. Considering risks are high, To avoid them or to elim...

In forum Risk Analysis for Medical Devices

7 years ago
RE: Design Verification & Validation vs Clinical & Pre-Clinical Trials

Devices which are used outside the body and which does not need clinical/ preclinical trials does not possess severe risks to patient. Few examples include sthethoscope, surgical tape, colostomy bags ...

In forum Introduction to Design Controls

7 years ago
RE: Design Verification & Validation vs Clinical & Pre-Clinical Trials

Devices which are used outside the body and which does not need clinical/ preclinical trials does not possess severe risks to patient. Few examples include sthethoscope, surgical tape, colostomy bags ...

In forum Introduction to Design Controls

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

Gantt chart should have all the outline which tells the project start date, end date, each project steps like planning, designing, developing, quality, manufacturing, testing and marketing. It also in...

In forum Introduction to Design Controls

7 years ago
RE: Important Part of DDP

DDP written by project manager is important which outlines all the developments of the project. Hence it is difficult to say one part is important in DDP. I feel all the steps involved in DDP are equa...

In forum Introduction to Design Controls

7 years ago
RE: Important Part of DDP

I feel that communication management plan is the most important because only if the people are discussing properly then they can find the flaws of a project and can be rectified in a constructive way....

In forum Introduction to Design Controls

7 years ago
RE: Consequences Of Insufficient Design Controls

Design controls always important for each class of medical device. For instance lets take pacemakers. If the design of pacemaker is not properly validated then the failure of pace maker would lead to ...

In forum Introduction to Design Controls

7 years ago
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