I believe that missing a milestone at any point is bad. Sometimes it can cause a hell to the project and sometimes not. When it come to any project that is affected due to missing milestone it can causes company a significant loss and some knowledge to learn for future. Even when you get out of any loss or no loss at all for missing a milestone it…[Read more]

One person working for multiple teams has its own pros and cons such as:
Pros:
It reduces artificial dependencies between projects.
Reduces induced administrativeand context switching overhead.
Increased domain knowledge and team cohesion.
It improves visibility and clarify on progress.

Cons:
Stagnation of technical skill sets.
Boredom and it’s…[Read more]

Risk management is process of identifying, assessing, reducing and accepting risks. Efforts to avoid, mitigate and transfer risk can produce significant returns. In a project risk there is a compliance risk that can greatly effect causing significant cost of changing products and its process also legal structures due to change new laws and…[Read more]

I read somewhere that closing phase has two important documents in the closure of the project. One is the formal project closure document and second is the lessons learned. Found it interesting and should be shared. Every project is different and it’s execution is also. It also has new problems and new solutions and new learnings from it. That is…[Read more]

Planning phase is the most important and basic phase according to me. If you are planning it should be practical because after all it has to be executed. Each and every step of any project should be planned that gives a clear view of what has to be done in a project. The Planning phase should include all the aspect such as execution, risks, design…[Read more]

I believe that if any project can wait to be done for that time it is not priority to complete it at that moment. Priorities are defined by timelines, if a project can wait while another project is currently been worked on and can’t be left in middle. Then that project is not priority for now and does not require to hire new employees. But if…[Read more]

Funding is the most essential part undoubtedly on medical industry. Anything attached with medical can cost more due to its safety regulations. For use internally or externally on human being. To be compliant with these safety regulations are needed even before it can be launched in market. To answer the question, sure this costs are more than the…[Read more]

There are ISO standards that are used by companies for launching any medical device in any country that doesn’t have their medical standards or if they are not clear enough. The countries that have their own medical regulation of medical devices prefer following them particularly in their country. There is also a part that results in non agreement…[Read more]

Proposals always have high expectations. I believe in order to provide a successful proposal you have to give more than that is expected from you. To put on new things or ideas on proposal makes them different from other cliches. This can be done by gathering ever idea from everyone. Ideas can give novel creations if put in a right way. Giving…[Read more]

I agree with Patricia. A project idea is tge gist of the whole project plus whole project relies on that in one way or other. I believe that to convince someone for any project with only an idea is not easy. Initiating a project idea is the point where whole project starts from. The design, overview, risks, liability etc. Thus it is an important…[Read more]

I agree that advertising is a sum of its parts. It is like the company is conveying the functions of the part that is made for. In other words, any device that is made is approved by FDA on the basis of it’s functions, working and it’s liability. Advertising is conveying those details to everyone. This details are necessary in order to get an FDA…[Read more]

Well ryan your way of thinking may be right but as we know FDA classification is more of risk based.Ibased.I believe that the device name looks like it must be class 3 device because it is attached to heart but risk of using the device is lower then any class 3 device that are more likely to fail when used. Maybe this is why it has been classified…[Read more]

Regulatory Standards for medical devices has a 3 class classification system that are class 1,2 and 3. They are classified on the basis of risk that is present while using them on a patient. As the class increases the risk of the device increases.

Class 1 medical devices have lowest to moderate risk. 47% of medical devices fall underclass 1 and…[Read more]

The use of unapproved devices during emergency is allowed but is conditional. The emergency situation is when there is a life threatening disease or condition that requires immediate use and no available alternative for life threatening condition. In such cases there is no time to obtain FDA approval. This condition is to be identified by the…[Read more]

I believe that teamwork in the workplace is an important factor for project success. Teamwork is important because it creates human synergy. It amplifies the results of each member of your team such that the overall result is greater than the individual contributions made by each member.
Clearly defining and communicating project’s vision and…[Read more]

A quality plan is a document, that together specify quality standards, practices, resources, specifications, and the sequence of activities relevant to a particular product, service, project, or contract. Quality plans should define Objectives, steps in the processes that constitute the operating practice or procedures of the organization,…[Read more]

I believe that the first and important skills are planning and scheduling the project according to the requirements of the projects. furthermore project manager gathers and analyzes information to prepare status reports, Ensures that assignment and scheduling of work follow Company policy and Regulatory Requirements.
Evaluates current procedures…[Read more]