I have learnt to work together and think outside the box. You can not just work with the information you have but also do research and see what else you can come up with. You need to know its not…   Read more»

It was interesting working with people you have never met before. This is what happens in the real world job, you are collaborating with people you don’t know. I have learned that you need to listen to other people’s ideas…   Read more»

My motivation is the people around me. If I know that I will be able to have fun and be able to talk to them freely, it helps me do the work and enjoy it also. I remember my first…   Read more»

Most people want to work because they want some sort of challenge but of course, they do it for the money also. But what drives people to go to work every morning is the environment they are in. The co…   Read more»

People leave work most of the times because they have a better opportunity waiting for them. But the reason they start looking for a new job is because they are getting bored at their current job and aren’t challenged enough….   Read more»

HR plays a huge role in any company. They go through the whole process of filtering candidates for the job positions, have many rounds of interviews with them and the hiring manager, and finally process the paperwork for everything. Finding…   Read more»

Two terms that have many interpretations because of the multiple definitions for the words assurance and control. One definition of quality assurance is: all the planned and systematic activities implemented within the quality system that can be demonstrated to provide…   Read more»

With failures in projects, it should be kept in mind that they will happen. We need to proceed without panicking and try to overcome the failures. In projects, they are always a setback in deadlines but that is why in…   Read more»

Design transfers are successful with communication and status meetings. These meetings should be used to keep everyone updated and also look at additional documents. Also a key factor would be to address any additional customer needs that were updated. Any…   Read more»

For a change request, it is also very important to look at the other documents that would be affects such as the SOP’s. For instance, if the name of the product is being changed, you need to have a change…   Read more»

When most medical device engineers hear the term “Design Verification” they think of one thing: testing. While it is true and very likely that Design Verification will involve testing, there are other acceptable verification activities. Design Verification activities can include…   Read more»

When most medical device engineers hear the term “Design Verification” they think of one thing: testing. While it is true and very likely that Design Verification will involve testing, there are other acceptable verification activities. Design Verification activities can include…   Read more»

Verification is a theoretical exercise designed to make sure that no requirements are missed in the design, whereas validation is a practical exercise that ensures that the product, as built, will function to meet the requirements.The purpose of Design Validation…   Read more»

ECO gives the chance for a team to see a mistake and have a chance to correct that mistake and document the change. This allows for teams to document changes carefully and also make sure the same mistakes do not…   Read more»

One of the most famous Six Sigma tools called DMAIC (Define, Measure, Analyze, Improve and Control) offers a structured approach for resolving organizational management-related issues. DMAIC can be understood as a troubleshooting-cum-improvement focused approach utility tool. However, relying exclusively on…   Read more»

Gantt charts are a valuable tool to have in project planning arsenal. Managers use them to perform a variety of project management (PM) functions, including: -Visualize the critical path. -Set baselines for project scope, budget and schedule—three metrics that are…   Read more»

The design review meetings were held with the head of the departments and each of the changes were reviewed and if anyone had any input to what else should be added or if any other changes should be made. These…   Read more»

At Prosidyan, the engineers redline the latest version of a document online using track changes. Before redlining, the engineer will create a DCO(document change order) with new revision and why changes are being made.The document record must be attached to…   Read more»

Risk–benefit analysis is analysis that seeks to quantify the risk and benefits and hence their ratio. Analyzing a risk can be heavily dependent on the human factor. A certain level of risk in our lives is accepted as necessary to…   Read more»

I do not agree with this statement of the book. I do not think medical device companies “lack transparency and proper clinical trials”. None of the medical devices will be in the market if they were not good. The FDA…   Read more»