I have sign a non compete agreement before and did not affected me from getting another job that I want. To my knowledge, non compete agreement is an agreement not to enter into or start a similar company or go…   Read more»

Oral agreement is as good as verbal agreement. A significant difference between oral and written contracts is that the time to sue for breach of an oral contract (the statute of limitations) is sometimes shorter.An oral contract is often provable…   Read more»

I enjoy the course and learn a lot. Although, I have some experience in medical device industry but this class has expand my knowledge and have me thinking of other profession in the field in can go in. The lectures…   Read more»

I would would like to work in Matrix Organization because of its flexibility to drawing employees from different functional disciplines for assignment to a team without removing them from their respective positions. It is good in terms of large and…   Read more»

I would choose Matrix Organization for a startup medical device company that will function worldwide because of its flexibility to drawing employees from different functional disciplines for assignment to a team without removing them from their respective positions. It is…   Read more»

Middle management is lower in position to Upper management. As briefly discussed in class and mentioned by you, the upper management are responsible for making the primary and strategic decisions within a company. This people are the CEO, CFO, CMO,…   Read more»

Matrix Organization would be successful in collaboration projects in which two or more companies come together to develop and manufacture a product. Matrix approaches to projects and other initiatives are typically less expensive than establishing dedicated project teams, and the…   Read more»

One of the factors of Risk-benefit analysis according to FDA provided guidance is Patient Preference. It explains the importance of knowing any available patient preference information. Also to consider the modality of treatment/diagnostic procedure and the risk tolerance. FDA would…   Read more»

Risk management meeting should be ran by sharing the complied list of risks from previous project, if any in order to identify some common risks but also as a catalyst to get the participants thinking about risks. Identify duplicate risks…   Read more»

Labeling, instructions and warnings are required for medical devices. But least effective at preventing hazardous situations and foreseeable misuse. Another way to ensure proper use by the customer for their own safety is that the company should make sure the…   Read more»

I agree Communication management plan is important but thinks quality management plan is equally as important. Quality management plan monitor and verify that project deliverables meet defined quality standards. Quality assurance activities monitor and verify that the processes used to…   Read more»

To add to what has already been said, Verification makes sure that you have objective evidence that user needs and intended uses are met. With a mindset to “break the system” thereby identifying any defects and functions that could result…   Read more»

A successful validation process contributes significantly to assuring the medical device quality and proves that the product produced is fit for its intended use. Quality, safety, and efficacy are all built into the product. I believe from the design stage…   Read more»

A whole lot as been said but will like to add that Good meeting minutes help drive a plan of action for your leadership team and employees. Help in the structure and state ownership.

FDA looks for the following: The quality system: Processes and procedures define and implement to describe how the company addresses medical device regulations. Design History File (DHF): Demonstration of Design Controls throughout the product development process is expected and required….   Read more»

The regulation of Medical Devices across the world is varies a lot, ranging from comprehensive to none. Some countries have a developed structure for regulation of Medical Devices, while some are partially done and the rest are either in the…   Read more»

The double blind study is more important in a clinical trial because it prevents the researcher from influencing the outcome of the experiment. Double-blind studies improve on experiments that compare the response of people taking a drug (or other treatment)…   Read more»

I will like to play the role of a Biostatician. To be able to involve in clinical research trial design, protocol development, data management, monitoring for safety and efficacy, data analysis and observational studies reporting.

Advantages of clinical studies includes the following: access to new treatments that work, improvement of future treatments and medical knowledge and discovery of fewer side effects compared to the standard treatment. Disadvantages of clinical studies includes; new discover treatment may…   Read more»

Clinical background is essential in clinical studies because majority of the roles you play has something to do with human life and in order to be successful in performing the task you need clinical knowledge. As stated in the question,…   Read more»