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…   Read more»

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. Everyone had different opinions,…   Read more»

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 require cross-functional operations. Therefore while…   Read more»

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 down through Document control) and verification deficiencies…   Read more»

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 follow based on the context.  Authoritative – In this…   Read more»

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 Amendments). The general controls include the provisions of the…   Read more»

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 project manager varies across organization types. In project-based organizations…   Read more»

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 importance and has worked on establishing a…   Read more»

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 unifying even more. The point of view is that…   Read more»

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 the developed app…   Read more»

I have not had much experience working in industry settings. But I think that I can share a brief experience I had at Brandix apparel solutions limited during a three-month internship. I and a colleague of mine were recruited from…   Read more»

Following up smartly is a necessary management skill, and with the pandemic, it has even become more important. Adding coworkers of the recipient as CC to an email sometimes helps in receiving a quick response. I personally like to receive…   Read more»

In the context project management I think that validation and subsequent verification have to be carried out by the project management team throughout the total project and not at a particular time. Validation and verification essentially make sure that the…   Read more»