While forming a project team, mistakes I would try to avoid are not been cooperative, lack of communication and effort. I think I would like to work with people who I am familiar with, it is always easy to communicate with people you know rather than complete stranger to avoid complication and hesitation.

I agreed with above discussions. I think it is very important for doctors, surgeons or who else is involve in using that device to have a training or at least instructions have been read before using any new medical device to avoid complications or delay.

Design transfer is the process in which the device design is translated into production, distribution, and installation specification.
Some of the common problem during Design transfer include
• Product developers do not have a finalized design.
• Manufacturing processes have not been validated, or documented.
• Safety issues
• Unresolved cost
•…[Read more]

Design verification and validation are the procedure to check during medical device development process that the product meets the specific requirements and error free. Design verification is testing that the design output meets the design input and requirements you have written. “Did you build what I said?” Design validation are intended to tes…[Read more]

Design input is the key point of medical device. If design input defined well during product development, it makes the rest of product development easier. Some sources state that establishing design input can take easily up to 30% of the project timeline. Sometimes people are in a rush to get the product to market and give very little time to…[Read more]

Design development plan(DDP) is a plan written by project manager, and it defines and describes all important aspects needed for the project. I think final scope statement is the most important part of DDP to provide understanding of project strategy, justification, deliverable, and scope of a project. I agree communication management plan is…[Read more]

Design control is required by FDA to check the medical device you design and develop is safe to use before you bring the product to market. Design Control is a procedure while developing a medical device to meet with specification requirements as includes
Intended use and design inputs
A design plan
Reviews design throughout the process
Design…[Read more]