The design input document and design specification document each play an important role in design controls as they are the documents that proclaim official descriptions of the design. After gathering a list of user needs and requirements, the design team…   Read more»

Verification and validation testing are performed to ensure that the project results align with the correct user needs and specifications. Rather than looking at it from the perspective of satisfying the FDA, validation and verification testing should be viewed from…   Read more»

Meetings can often cover a lot of material and if meeting minutes are not recorded then there is a decent chance that some of the topics will not be acted on after the meeting. I have participated in meetings regarding…   Read more»

It is difficult to exactly pinpoint the issues that arise from insufficient design controls, since the process of design controls has 9 parts within it: planning, input, output, review, verification, validation, transfer, design changes, and design history file. If a…   Read more»

A risk vs. benefit analysis can also be done to decide whether one should outsource or perform in-house production. With in-house production, one may face risks with money, especially for smaller companies which may not have the best equipment to…   Read more»

Another way to choose which test to perform is to look at previous studies’ design specifications and question how they obtained those specifications. For my senior capstone project, we did a lot of research into the design specifications listed for…   Read more»

Pemoline is used in the treatment of attention deficit hyperactivity disorder, it is banned in the USA. It is still continued in India. It was banned in the USA because of its liver toxicity risk.

Its actually fun and interesting to work with people with diverse backgrounds and cultures as there is an exchange of thoughts. It helps an individual to learn new things and helps adapt oneself to diverse surroundings. During my internship, the…   Read more»

Generally, the project manager position is given to people with experience. It would be better to have work experience priorly as it will give you an idea about the whole work process first. But if you want to plan a…   Read more»

Currently, I am doing a co-op. At my workplace I have more than 1 manager for the project. I feel that having more than 1 manager is actually good as the other substitutes for the absence of the other manager….   Read more»

I think the project manager be someone who likes his/her work and puts in 100% for achieving a goal. The person should be able to keep calm and should have a strategy that will work under any circumstances. He/she must…   Read more»

Considering all design development plan (DDP) areas final scope statement, scope management plan, quality management plan, communications management plan, and team member responsibilities have similar interest. However, I think the scope management and team responsibilities are a bit more substantial…   Read more»

Design Controls are pre-marketing assaying methods, which were created by FDA in 1996. The design controls duration starts with the project initiation until the final product is tested properly. Design Controls areas involve design of planning, input, output, review, verification,…   Read more»

As this week material showing, the design input document (DID) is an overview and short description, and the design specification document (DSD) illustrates a specific technical design data, the selected material data, and dimension information. Both are important for group…   Read more»

I come from a non-BME bachelors degree. I personally believe that a BME background is necessary to get more understanding and clarity towards the future goal if you wanna be a biomedical engineer working in a medical field. Masters will…   Read more»

BME is very diverse in all aspects. Basically, it has a lot of areas to work upon. That’s what makes it more interesting. Currently, in my coop, I am working in Quality Assurance. As Biomedical Engineers we have an opportunity…   Read more»

The benefits of outsourcing the design transfer into the manufacturing process are leveraging multidisciplinary expertise to have breakthrough ideas from other industries and technologies and be able to expand without needing to maintain the technology in-house.  I agree that small…   Read more»

A design specification document (DSD)is a detailed document that provides information about a designed product or process. The design specification must include all necessary drawings, dimensions, environmental factors, ergonomic factors, aesthetic factors, required maintenance, details on performing the work, etc….   Read more»

The different areas of the Design Controls allow for each section of the project to be organized and ensure the product released is of the highest quality. Without design controls, the company is running the risk of their product not…   Read more»