The tests to assess the biocompability of the material should follow ISO 10993. The following tests should be done on the biomaterial for verification and validation of the product: Evaluation and testing within a risk management process, tests for genotoxicity, carcinogenicity and reproductive toxicity, tests for in vitro cytotoxicity, tests for…[Read more]

While working on a project, we hit a roadblock during the verification phase. Before this obstacle, we have already spent most of our time and budget on the project. Before submitting 510k for our product, we had to complete a strength testing of our material. The material and the product design failed to pass the specification and thus we had to…[Read more]

I think the challenges are different for other industries as opposed to medical device. These differences are in the regulations involved on a project of respective industries such as building a school. For instance, projects in the medical device industries need to take into consideration the FDA regulations, such as 510(K) clearance. While…[Read more]

I think initiation and planing phase is most important because in this phase you define your baseline. During these phases we gather the requirements and specifications for the project. Scope is defined in these phases which gives better picture of the project. Project objective are also constructed in this phase which helps in accuracy of project…[Read more]

Since working in both academia and industry, I have experienced both pros and cons. Working in academia allows you to take in-charge of your project and choose your own direction. You can freely choose your own objectives and goals regarding the projects. Meanwhile in the industry, the deadlines and project objectives are dictated by your…[Read more]

I think this is not an appropriate ratio because students need more exposure to the practical tools to succeed in the industry. Practical knowledge allows you to gain the specific techniques that become the tools of your trade. Practical knowledge leads to a deeper understanding of a concept through the act of doing and by gaining personal…[Read more]

I want to keep working as an Engineer because I will be directly involved in the project. Engineer also have an important part to perform in the project. If an engineer’s job is done so poorly as to make the product non-marketable, the product will fail and won’t be used. When the quality along all dimensions passes the adoption threshold, every…[Read more]

I would take the opportunity to review the financial stability of the vendor as problems often mean an unprofitable company.I would also look at the performance of the vendor coupled with their direct and indirect benefits is compared to the physical cost of doing business with them. These costs would include such matters as: overpricing, early…[Read more]

There was an instant when one of our lead Engineer was removed from our team. This really pushed our timeline of our project back several week since we had to evaluate and assign his tasks to another member. The project also missed his expertise on certain topics. At the end, he was asked to work on both project simultaneously.

Health apps could be considered a general wellness product. These apps allow users to count their daily calories and facilitate their exercise routines. Therefore these apps help to maintain healthy lifestyle and prevent the chronic diseases. I consider this product as a second category since it makes a direct reference to the diseases such as…[Read more]

Most of the verification and validation tests are carried out by international standards such as ISO or ASTM. These standards specify the testing for strength, biological and chemical properties of the material used in product. For example, ISO 6872 specifies the requirements and the corresponding test methods for dental ceramic materials for…[Read more]

Working at the dental implant company, I have been exposed to the design control that have been mentioned in the lecture. During the beginning of the project, the general purpose of the medical device or its function is established. This is defined as the user needs which are communicated by the marketing team. After that design and development…[Read more]

I disagree with the posts above. The verification and validation covers all phases of the product development cycle. Its really critical to start the verification and validation at the beginning to establish the user needs and product specification. During the product development, verification is done to see if the product design input satisfies…[Read more]

Applications whose functionality poses a risk to a patient’s safety if the mobile app were to not function as intended are considered mobile medical applications. Therefore app to retain the auditory cues is considered the mobile medical application. Furthermore, FDA states that “Mobile apps that use tools within the mobile platform (e.g., s…[Read more]

We can have better understanding of the “significant risk” by reviewing the FDA’s requirement to review all the adverse events. The medical device reporting regulation states that a serious injury is one that is life threatening, results in permanent impairment of a body function or body structure, and makes necessary medical/surgical…[Read more]

The project management at my company is advanced and uses visual project management system to manage projects. Each project begins with the master schedule set up by the member of each department such as quality, product development, material research, process development and regulatory affairs. The master schedule includes 4 stages with major…[Read more]

I think project management skills are transferable to the different industries to a certain extent. Project managers possess the skills such as leadership, communication and punctuality that can be applied to any type of project in different industries. Good project manager can utilize these skills to drive the project to the completion in a…[Read more]

I work at Nobel Biocare which manufactures dental prosthetics. I consider this organization as a functional based one since this organization structure is a hierarchical organization structure wherein people are grouped as per their area of specialization. Each department have its own manager who will be responsible for the performance of his team…[Read more]