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 as Quality Control is a technical function that includes all the scientific…[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 of the most important factors in a successful project. Lack of communication can lead to…[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 an effective Design Development Plan. This would have provided us with the oppurtunity to carry out more experiments…[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, routers, bill of materials and…[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 risk analysis.
It is important in Project Management as design…[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 projected goal.
3. Business Experience and Reputation
4. Qualifications, Backgrounds, and Reputations of Company Principals
5. Risk Management…[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 a lead center, is based on a determination of the “primary mode of a…[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 in core development. The design inputs for a successful medical device should include
a) functionality, performance, and…[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 and advice us on how to move forward with our project idea. During our first meeting my internal guide heard my teams idea and asked…[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 for further approval. There is a possibility of alteration of the CO based on the input recieved…[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 needs to be monitored throughout the developmental process. Hardware risk can be monitored using a modeling software where the…[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 that ensure the safety and effectiveness of regulatory devices. This regulatory…[Read more]

According to me, the first, and most critical, step to initiate a project is defining the extent of the project. What is it you should achieve or make? What is the task objective? Similarly important is defining what is excluded in the scope of your project. On the off chance that you don’t get enough definition from your supervisor, illuminate…[Read more]

I agree with all the comments made here, and would like to add mah52’s plastic syringe example that as plastic is chemically inert, use of a different grade plastic material would not require a PMA. Also the syringe wouldn’t be coming in contact with the body, so there is no chance of occurrence of infection. Even if it did come in contact with…[Read more]

We’re full of ideas of what would make the best business plan and are convinced that it will earn us plenty of money. To convert these ideas into words and convince investors to see the success of this idea as we see it in our head.
The business part of the project begins from the conception of the idea as you have to “sell” that idea to potential…[Read more]

I would like to work in a matrix based organization. I agree with the points made by smitshah and srg36. I would like to add this type of organization will result in good management of resources, it encourages people from different departments to come together and share ideas. The more ideas are shared, the more is the productivity of the team. As…[Read more]