I agree with you, lets say a company is getting sued, no verbal agreement will be taken into account in court. There is no proof that will back your claims. Only written agreements are known to be reinforce your case….   Read more»

Verbal agreement and Written agreement are totally different. One is more important than the other. First of all verbal agreement nothing is guaranteed. Verbal is all talk, and most of the time it is just discussion on what ideas they…   Read more»

I agree with you, I also prefer the Functional organization if you are starting up a company. Yes matrix organization seems a lot more helpful, let’s say some is stuck and needs help there are many people who can help…   Read more»

I agree with you that communication is a major key in team work. Communicating as a team makes the work a lot easier and working as a team. If their is no communication this can lead to group conflict and…   Read more»

I believe this can go either way. In a company people build relationships with other people and they work as a team. In my opinion it is better to work with a team of individuals who are more knowledgeable in…   Read more»

As we all learned in risk management, Failure Modes and Effects Analysis (FMEA) and fault tree analysis (FTA) is a valuable tool used to evaluate errors in medical device designs. In my opinion if risk analysis evaluated earlier there is…   Read more»

I agree with you, analyzing the device as team at all angles is really important. There are times when other may catch mistakes that you have missed. This goes for all departments or areas. As a company, employees need to…   Read more»

It is kind of shocking that many companies basically do not follow through after the production of a product. In a business standpoint, customers would want a product that will not have any flaws. To ensure a product is safe…   Read more»

Meeting minutes is basically important protocols discussed at a meeting. Basically meeting minutes covers all the topics discussed during a meeting, such as the current status of the project, any issues with the project, and schedule of and what has…   Read more»

I agree with you that larger companies would benefit the outsource the design transfer. The goal is if all specifications are completed efficiently, the companies would save a lot of money and time to do other work. Larger companies have…   Read more»

Outsourcing is a great way for large companies to save money and time. The risk of outsourcing is making sure the vendors are given a proper procedure for the product. Everything must be completed according the their instructions. If not…   Read more»

Design Inputs are the key for medical device development. This is basically how a company can build its foundation on a certain product. In my view, design input is the start up of a device. This device must be approved…   Read more»

I’m not sure which part would be more important because all phases are needed to have a successful project. It is very crucial that DDP is followed thoroughly. I feel planning and scheduling is very important. Making sure all deliverable…   Read more»

Design Verification & Validation seems to be interchangeable sometimes and can be very confusing. In medical device there is a way to separate the two. This is how I tell the difference between V&V. First, Design Verification is when a…   Read more»