I enjoyed reading all the comments in the post and was pleasantly surprised to see how similar the views of everyone here are to the consensus posted in the question. I too would personally agree with the overall results of…   Read more»

To ensure a good relationship with vendors we need to keep the following points in mind: 1. Explain your business goals making sure the vendor understands your vision. 2. Pay your bills on time. 3. Assign a dedicated vendor manager….   Read more»

I would like to work in the Regulatory department if I was part of a clinical project team. Being someone who is always thorough with every step she takes, always planning two steps ahead and always ready with a plan…   Read more»

I would like continue being an engineer. I would like to find my area of interest, build my expertise over the years and a reputation in the industry. Once, I’m at the senior, expert level, I would like move ahead…   Read more»

What motivates me to work the hardest and put my best foot forward is my desire to learn new things. I work the hardest on a project and like doing everything from scratch because I love how much I learn…   Read more»

The Six Sigma methodology DMAIC (Define, Measure, Analyze, Improve, Control) offers a structured and disciplined process for solving business problems. Six Sigma uses tools designed to identify root causes for the defects in processes that keep an organization from providing…   Read more»

I agree that there should be a common communication management plan that is included as the SOP. This assists in the effective dissemination of information.The information distribution can be designed in compatibility to the project organization chart ensure easy flow…   Read more»

Quality assurance is a management or oversight function, it deals with setting policy and running an administrative system of management control that cover planning, implementation and review of data collection activities and the use of data in decision making. Where…   Read more»

Each factor has its own contribution towards a successful project completion. 1)Agreeing on the project goals helps the team have a clear idea of what is expected of them, and sets unanimity amongst the team members. 2)Effective Communication is one…   Read more»

At the completion of my capstone project, the most important learning that I took away from it was the importance and significance of the Planning stage during a project. Though the project was completed in time, if we had deviced…   Read more»

The factors that need to be considered during design transfer are that complete information is provided to production about the manufacturing of the product. This includes manufacturing work instructions, Item Master, Quality inspection work instructions, Procurement instructions, drawings, tooling specifications,…   Read more»

Design Validation is carried out by by examination and provision of objective evidence that ensures that device specifications conform with user needs and intended uses. It includes testing of production units under actual or simulated use conditions, software validation and…   Read more»

While selecting from a list of vendors the PM needs to keep a number of things in mind : 1. Legal and Regulatory Compliance of the vendor 2. Financial Condition of the company to make sure it can reach the…   Read more»

I would further like to continue this topic by asking what types of marketing applications are required for a combination product?

Combination products are assigned to a FDA center that will have primary jurisdiction for its premarket review and regulation. Consistent with section 503(g)(1) of the Act, assignment to a center with primary jurisdiction for premarket review and post-market regulation, or…   Read more»

I agree with all the points that Devarshi has made and would also like to add that Solid Design Inputs makes the rest of medical device product development easier too. Once Design Inputs are defined, you are ready to engage…   Read more»

In the final semester of my undergrad we were required to work on a project that would be equivalent to the capstone project here in NJIT. Each team was assigned an Internal guide who would help us plan our project…   Read more»

The objective of ECOs and any other change orders is to legitimately archive the proposed changes for tracebility purposes. Any necessary changes of the design or documentation go through COs. The COs are reviewed and sent to the necessary dpartments…   Read more»

A product risk can occur due to a defect in the drug release mechanism in a drug delivering device. Under FMEA a drug delivering device would be a Concept Design / Hardware risk where the probability of success of design…   Read more»

That is an interesting topic. Medical Devices are categorized based on the risk associated with the usage of the device. The categorization is based on different parameters such as 1. The general regulatory controls: General controls are the fundamental provisions…   Read more»