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 into competition against the company you’re currently working. The agreement usually lasted for about three to five years after one left…[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 by action taken by one or both parties which is obviously in reliance on the existence of a contract.…[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 are clear and very well explained. Discussion in forum is a very good idea, you get chance to express your thoughts on a particular…[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 long time projects management. Employees in a matrix organization report on day-to-day performance…[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 good in terms of large and long time projects management. Employees in a…[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, CSO ect. While Middle management are responsible for implementing the top management’s policies and…[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 diversity of the team members makes them superior to many purely…[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 disapprove the IDE application in accordance with 21 CFR…[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 and work as a team to determine other risk associated with the product. Assign impact of each risk and…[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 benefits of the medical device outweigh the residual risks, then the device can be…[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 manage and create the deliverables are followed and are…[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 in hazardous situations leading to harm. As mentioned early verification testing; start testing design on sim…[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 through commercial production, validation process should establishes scientific evidence…[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. The User Needs of the medical device. Design Output:…[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 process of developing a structure or do not yet have any regulation.
A country like Indonesia have a…[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) to those who do not. Even though, neither the investigator nor the ones taking the…[Read more]