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 work as a team to make sure it is succeeding. This is why I think having full cycle evaluation will only benefit the company. I…[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 and with no flaws it is best for a company to make sure the product goes through a full cycle of analysis, especially…[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 to be completed before the next meeting.

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 so numerous task to complete, outsourcing their product saves a time to do more project to make more money. I…[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 the company is at risk and will be at lost. In my opinion outsourcing is a pro, many of these large companies…[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 of all it’s design inputs, meaning all its designs and manufacturing process must be acsepted first. Any medical device, must b…[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 for every week or month is accomplished. By schedule I mean all the work on a certain design or part of a p…[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 team correctly designs the device. While design validation, did the team make the correct design. Furthermore…[Read more]