Mobile medical apps are mobile apps that meet the definition of a “device” which are intended either: 1- To be used as an accessory to a regulated medical device; or 2- To transform a mobile platform...

Further, according to FDA, a “general wellness product” falls into one of two categories, and either: Has (1) an intended use that relates to a maintaining or encouraging a general state of health or ...

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 t...

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 all...

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 ver...

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...

Hi Everyone, According to the attached article "NDA_Basics: The ABCs of NDAs": "NDAs are contracts, and usually understandings between two ethical parties. Before you rely entirely on an NDA to protec...

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...

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 enti...

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, w...

As Dr.Simon mentioned about Risk management meetings: - Happen throughout process Subsequent meetings to go through process: Evaluate -> Manage -> Measure May need to go through multiple times S...

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 somethin...

Risk-benefit analysis is the comparison of the risk of a situation to its related benefits. The FDA provided a guidance about the benefit and risk factors to be considered for making decisions concern...

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 prov...

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 a...