Regulation of medical devices is different across the world. Some places have very complex requirements while others have none at all. In the U.S., we have established Design Controls. Design controls designate the application of a formal methodology to the conduct…   Read more»

As a Project Manager, the key to helping underperforming employees is to act as soon as you start noticing signs of underperformance. Upon noticing changes in their work behavior, you should schedule time for a one-on-one meeting. During this time…   Read more»

Verification and validation are both elements of the medical device testing process, they serve two very different but equally essential functions. In simple terms, verification determines whether the product was built right, while validation determines whether the right product was…   Read more»

There is no set way for a company to decide on its project management. There are advantages to both methods. When having members of the same company be part of the project management team, the team will contain members that…   Read more»

Remote employees are working longer, spending time in more meetings, and having to keep up with more communication channels. Instant messaging platforms are best for short messages that need a fairly immediate response. Email is usually better for longer messages…   Read more»

My team’s approach to the simulation was to first list all the possible roots of the problem. Then, we would list them in decreasing order of how probable they would to occur. After that, we would conduct some research on…   Read more»

It is important to have check points to constantly monitor the activity and project level. I believe that it is more likely to go under the planned value because there are usually some obstacles that occur that would inhibit the…   Read more»

Hi all, I am a PhD student in the BME department at NJIT. 
Here is my linked in profile 
 
https://www.linkedin.com/in/alexandros-tzalavras-aa9000170/

@jbarbee I agree, I think there is value in having an internal PM and also having fresh eyes from a third party service come in to evaluate and assist in the implementation as well. 

In my most recent role, the company was fairly large and there was a PM but there was no PM team. The project manager would enlist the input/services of an individual from the internal team the project focused on, to…   Read more»

There is most certainly an ethical component(or lack there of) when it comes to releasing medical devices or anything consumers could sustain harm from without proper testing. There is a reason why there are established statutes in place that allow…   Read more»

All of the components associated with design controls serve a necessary purpose. However, the design verification process and design validation processes are the most important. Both the verification and validation procedures, in addition, to the DID and DSD, allow companies…   Read more»

The underlying purpose of the DSD and DID is to ensure the customer’s needs are satisfied. To develop a product effectively, the company must meet the overall perspective of the product and the detailed functions as well. The DSD ensures…   Read more»

The verification process is crucial for several reasons. For one, if customers are the first to identify the flaw(s) in a product, that diminishes the company’s credibility. It also demonstrates the company’s attention to detail. One way to improve the…   Read more»

When I interned with the Navy, a large portion of my time was spent in classes teaching different teams how to implement Scrum or different agile thinking methods to improve productivity. To prioritize the way that tasks were sequenced in…   Read more»

When I like to tackle a challenge, I find it very helpful to alter one variable at a time. In this simulation, by changing the packaging and medicine at one time, a concrete solution could not be determined if this…   Read more»

I would first hold a team meeting, as many others before me have said. At this meeting, I would ask questions that pertain to goals or tasks the previous project manager has put into place. This will generally give me…   Read more»

I agree with all posts here, that communication would be a very large part of getting the team back on track. In addition, I agree with @ridmehta, in having a sit-down meeting with each team member individually. I would want…   Read more»