I think it all comes down to communication and accountability. The team should have some sort of idea what the others are working on. Another thing of the key characteristics of an effective project team is that the team members have the talent, knowledge and familiarity necessary to accomplish the undertakings assigned to them.
Also, networking…[Read more]

I found too many companies charged for illegal kickbacks violations for example:
1- In North Carolina, Minneapolis-based Cardiovascular Systems, Inc. (CSI), has agreed to pay $8 million to resolve allegations that it paid illegal kickbacks to induce physicians to use the company’s medical devices from kickback allegations. As we learned ” The f…[Read more]

YES you can start your project based on a verbal agreement, but you need to make a prove for this verbal agreement, but if you failed to prove the agreement so you will be a loser. As we learned a verbal contract can be oral or written, but an oral contract is any agreement that two or more parties make based entirely on spoken or orally…[Read more]

I think every one studying BME should take this class. I have learned a lot about medical device development. This course helped me to learn a lot about the regulations in and out of US, how to make a design control, quality assurance,…the material is very good and explained in a professional manner.Also, I think its a great idea to take the…[Read more]

Middle Manager, I think ‘middle managers’ are an employer’s most important leaders .Although middle managers may be work under increased pressure and feel more stressed,but they are strongly committed to the work itself.
A middle manager’s role may emphasize:
– Executing organizational plans in conformance with the company’s policies and the obj…[Read more]

I think Project-based Organization manager is better than being a manager in a matrix-organization.
A project-based organization manager have a lot of power and easier to run projects because the entire structure is set up for that purpose. Also, in project-based organization, managers have a high level of
authority to manage and control the…[Read more]

I would like to work in matrix-organization, which all departments work closely together and communicate with each other frequently to solve issues (teamwork).The structure of a matrix organization, which is built on relationships between departments as a matrix, is better than the traditional hierarchy .Though a matrix organization is meant to…[Read more]

As we have learned, Risk Management is done on multiple areas of a project, not just one:The product, The product design, and The manufacturing process.
A method to analyze risk
Looks at:
HOW something can fail
SEVERITY of the consequences
PROBABILITY that it will fail
you also can apply DFMEA – Design Failure Mode and Effect Analysis
Apply A…[Read more]

A key for each medical device company is: Keeping up with changes to ISO 13485:
” specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”

Also:

ISO 14971 specifies a…[Read more]

Example For Verification process:
If you said in Design Input Requirements ” The MRI machine’s electrical system shall operate at 120V at less than 16 amps ”
So, for Design Process ” Components such as motors, actuators and LEDs rated for 120V that will meet functional requirements will be specified but will not exceed a total of 16 amps during o…[Read more]

I did research about the regulations in India, and I found that, India is one of the largest medical device markets in Asia, and is still growing at an impressive rate. Prior to 2005, no medical device regulations existed in India! -(System C as DR.Simon mentioned),
The registration process for medical devices in India remains fluid, but…[Read more]