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 good that these rules are set. This will not give chance for bribery.

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 by its owner so as to protect his/her idea. NDA is signed prior to the patent process.

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 agreement is always better since there is proof/evidence that can be shown in court in case of any legal disputes.

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 transfer between the departments. Matrix organization helps in a more effective way of running a project.

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 experience to understand the company’s vision and goals. Hence, climbing the ladder from bottom to top along with experience is my way of growing.

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 events can really have productive results in connecting others. Also, to have a strong and motivating project manager generally solves all of these problems.

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 product is in the market, a company should keep a track of how the product is functioning, are there any risks which have occured etc. From these data…[Read more]

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 also along with that its good to tell the associated risks if not used in the way it should be used. Like this it can create little awareness in the…[Read more]

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 eliminate them is a good option rather than taking any chances. Mitigation or acceptance could be choosen for low severity risks because its okay to…[Read more]

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 etc. These devices does not pose risks to patients and only verification and validation is sufficient rather than preclinical/clinical trials.

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 includes budget planning and resource planning. The dates should be flexible enough that the gantt chart should consider mistakes and errors and…[Read more]

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 equally important. Communication management plan which helps to communicate people in the project is as equally important as quality management plan…[Read more]

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. If there is not proper friendly approach between the team members the members will be ignorant towards each other work and the project would be not…[Read more]

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 the death of a human. In a generalized way design control of a medical device/drug should be considered because the consequence would more serious…[Read more]

Despite its small geographic size, Singapore has one of the largest and most advanced healthcare systems in the world. Singapore has robust healthcare infrastructure, so there is consistent demand for state-of-the-art medical technologies. Medical devices in Singapore are regulated by the Medical Device Branch of the Health Sciences Authority…[Read more]

Advantages and disadvantages are associated with clinical trials. Performing a clinical study is important for the drug/ device to be tested for its effectiveness, safety and risks and to come into market. If a drug or device can save thousands of lives, then doing clinical trials to test it is worth enough considering its risks and benefits.…[Read more]

I would like to become a Clinical Research Associate if i would take part in a clinical research. It directly involves in carrying out clinical trials to test the effectiveness, safety, benefits and risk associated with the drug/ device so that they can be marketed. This interests me because i can be responsible from start till end of clinical…[Read more]

Clinical experience is not needed for all the roles. Roles which does not involve any interaction with patients, communication with patients like statistician etc does not need any clinical experience. But for roles which is directly involved with patient interactions like nurses, physicians etc, having a backgound of clinical experience becomes…[Read more]

Emotional Intelligence helps companies to understand the customers emotions, mood, behaviour and to control them. It helps companies connect with the customers, have good communication to know the current needs of the customers and also to get feedback. EI is obtained by asking customers itself about their current needs, feedback, ther opinions…[Read more]

One of the product that is doing good without the Telisvision or other form of advertisements is Zara. It is one of the worlds largest retailers and does not have any budget for advertising. Instead of that the company uses money to buy expensive storefronts next to luxury retailers so that they can make themselves leaders in affordable luxury.