Balancing communication methods is very important practice to be able to keep projects running smoothly without wasting valuable time. Some good strategies are to tailor communication to the type of i...

Organizations are able to maintain balance between control and flexibility through setting clear guidelines and actually structuring how to make project changes. Defining the scope of creativity and e...

Project execution is rarely static, especially in fields like medical device development where shifting regulations, sudden roadblocks, and changing priorities are the norm. Adaptability isn’t just a ...

Effective planning can be very essential for the managing of various complex demands in medical device development. This can include but not be limited to including meeting deadlines, staying within b...

From my experience project risks come in various forms which include financial, schedule, resource, and quality risks which can all impact a projects success differently in their own way. One common f...

Balancing rigorous design controls with the flexibility that is needed for innovation is crucial in various regulated industries like medical devices. While strict design controls ensure safety, accou...

If you were to start a project without a clear proposal and a feasibility study in can lead to scope creep, resource misallocation and unexpected challenges. A well-structured proposal will align stak...

Slack is a very crucial element in project planning because it helps accommodate for the unexpected, like delays, vacations, holidays or various emergency closures. Including slack in your schedule al...

As far as I know PMA and 510K's are two pathways to get FDA approval to sell their product to the US. For a 510K the company is saying that their device is similar to a device that is already approved...

A drug is a treatment that works through a chemical or biological interaction with the body which can impact various cellular pathways or physiological functions to treat, prevent or diagnose diseases...

Personally in my field, team size depends on the types of projects you're working on. Since I work in the development of In-vitro models the kind of research we do can really only be done by one perso...

In my opinion, good leaders are born with emotional intelligence, and learn how to manage projects logistically in the company. A good leader takes into account both the logistics of the team, their s...

When someone signs an NDA it is very crucial to review and understand the agreement as best as possible, some key considerations is the definition of confidential information, the level of confidenti...

I found that this course ended up focusing on the practical aspects of the medical device industry rather just the theoretical knowledge which was very interesting, there were a lot of insights into t...

In my field written agreement is a very important aspect of our work. When we share research outside of the company we have to come up with agreement documents to outline what information is to be sha...