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 ris...

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 compa...

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 ...

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 issu...

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...

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 acc...

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 devi...

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 i...

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&...