Sometimes milestones are missed when there is project scope change, in this case, it is vital to start realizing that the defined scope should be reclarified and roles and responsibilities should be r...

A good starting point might be to check whether your test conditions are just too strict, what if over-verification is performed. I think that it is always valid to ask yourself after a test failure w...

Understanding the requirements and establishing a robust project definition is paramount for the success of the project. Spending more time on the initiation and planning phases is a long time investm...

Earned Value Management highly depends on quantitative project planning. This is not practical for some novel and agile projects. Some modern projects which are always open to change utilize methods s...

In addition to fault tree analysis and FMECA which are widely used, revealing severe hazard potential as early as possible is very important. Preliminary hazard analysis conducted as early as in the c...

As I do not have any experience to share here, I would like to discuss a few new terms related to the topic. The tendency of an organization or group to take risks in a given situation can be termed a...

I can recall a machine design project from college where we had to design a Cam Tester together as a total class. In the beginning, bringing everyone together was a hard job for the team leader. Every...

Being a project manager in the medical device industry requires being able to cope with ambiguity and the ability to be able to handle constraints in budget, scope, and time. Most of the projects will...

Procedures need to be established and maintained by the company to document design changes. This is a requirement of the FDA. These procedures have to cover both direct design changes (these are set d...

As various interpersonal skills and traits of a good project manager have already been well discussed in this topic I would like to introduce some management strategies that project managers can follo...

About 47 percent of authorized devices in the market are class 1 devices. These devices should comply with general Controls (the basic provisions (authorities) of the May 28, 1976 Medical Device Amend...

The project management approach highly depends on what type of organization it is, and so identifying the suitable type of organization is crucial for project success. The authority given to the proje...

In 2017, 82 percent of total devices cleared by CDRH were through the 510(k) pathway and so the importance of keeping the 510(k) updated is very clear. In recent years the FDA recognized the importanc...

Project management is, for the most part, less of a science and more of art. Therefore, I believe that categorizing or formalizing the practices in project management is extremely difficult and unifyi...

As the hearing aids used in your project would fall under the category of regulated medical devices (as they would be in section 201(h) of the FD&C Act and cleared as already in the market) and as...