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Bhargav replied to the topic "General Wellness Product" – 5 years, 10 months ago
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… Read more»
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Bhargav replied to the topic "Tests for validation and verification phase" – 5 years, 10 months ago
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… Read more»
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Bhargav replied to the topic "Experience with Design Control" – 5 years, 10 months ago
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… Read more»
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Bhargav replied to the topic "Best timing for validation and verification" – 5 years, 10 months ago
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… Read more»
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Bhargav replied to the topic "Mobile Medical Applications" – 5 years, 10 months ago
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… Read more»
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Bhargav replied to the topic "Significant or non-significant risk" – 5 years, 10 months ago
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… Read more»
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Bhargav replied to the topic "Discussion Topic: Share your project management experience" – 5 years, 10 months ago
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… Read more»
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Bhargav replied to the topic "Discussion Topic: Projects of all types" – 5 years, 10 months ago
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… Read more»
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Bhargav replied to the topic "Discussion Topic: State of your Organization" – 5 years, 10 months ago
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… Read more»
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Bhargav replied to the topic NDA vs Patents in the forum Consultants and Legal Basics 7 years, 4 months ago
NDA would not substitute for the patent. NDA is helpful for your legal case when the person who signed the NDA uses company’s idea as his own. However, NDA is not useful when the person who signed the NDA reveal the idea to the third party.
On the other hand,patents protect the idea from the people who innocently and coincidentally come out with…[Read more] -
Bhargav replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 7 years, 4 months ago
I think that oral agreement are often looked upon warily because they are not easily enforceable. Contract that are written are can be easily presented for a legal defense than the oral testimony. It is also difficult to remove contract defects when they are not in writing.
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Bhargav replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies 7 years, 4 months ago
I work at the company 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]
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Bhargav replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
One of the method to use from the design perspective is R & M or reliability and maintainability. As a Design engineer, I want to make sure that the product will be reliable after further use. The product should also have low cost and easy maintainance going forward. The causes for maintenance and operating costs need to be studied in the initial…[Read more]
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Bhargav replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
There were a lot of mistakes can be made while implementing the FMEA. The mistakes cause the FMECA not meeting the objectives of it. Conceptually, Poka Yoke is able to fit into the Process FMEA. Failure Mode and Effect Analysis (FMEA) helps predict and prevent problems through proper control or detection methods. Mistake proofing emphasizes…[Read more]
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Bhargav replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls 7 years, 5 months ago
I believe that design controls should be part of the process used to determine the commercial viability of a product in development. Design input requirements can help customers and stakeholders identify and satisfy product requirements. Another vital part of the product development process is design output. A medical device cannot exist without…[Read more]
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Bhargav replied to the topic Discussion Topic: Mission and Vision statements in the forum Marketing and Sales 7 years, 5 months ago
A mission statement communicates the organization’s reason for being, and how it aims to serve its key stakeholders. Customers, employees, and investors are the stakeholders most often emphasized, but other stakeholders like government or communities can also be discussed.
A vision statement, in contrast, is a future-oriented declaration of t…[Read more]
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Bhargav replied to the topic Discussion Topic: Emotional Intelligence and its affect on sales in the forum Marketing and Sales 7 years, 5 months ago
The four branch model as the construct of emotional intelligence: (1) the ability to accurately perceive, appraise and express emotion; (2) the ability to use emotion to facilitate thinking; (3)the ability to understand the temporal course and probable outcome of emotions; and (4) the ability to regulate emotions effectively.
Today’s m…[Read more]
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Bhargav replied to the topic How Quality Departments React to Audits in the forum Quality Control and Quality Assurance 7 years, 6 months ago
I have not been a part of the audit during the the FDA or BSI visits. However, I have been called during the visit regarding the documents that I have written. Their main objective was to clear out the inconsistencies in the reports. The documentation meets the defined quality objective of the organizations The activities performed are in…[Read more]
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Bhargav replied to the topic Discussion Topic: e-cigarettes in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
In 2016, the FDA issued a final deeming regulation that will regulate e-cigarettes as tobacco products, but the regulation, while addressing some key policy issues, still leaves significant regulatory gaps. In addition, the regulation will be phased in over the next few years, so even if it is not delayed as a result of litigation or other…[Read more]
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Bhargav replied to the topic Academia vs. Industry Research in the forum Pre-clinical Device Development 7 years, 6 months ago
There are many differences between doing research in academic and industry. I have had experienced both during my career. Amount of time given to the research in industry may not be as comparable to academics. However, proper structure in industry drives efficiency with the amount of time provided.
There were many factors that insured that I was…[Read more]
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