This course really helped me understand what actually occurs in the medical device world and what the work will be like day to day. I enjoyed seeing each step of the development process in a way that ...

Conflicts in medical device consulting agreements are common because these contracts involve strict regulatory expectations, intellectual property concerns, and high financial stakes. To deal with the...

A written contract provides documented and clear evidence that can be utilized in court. An oral contract relies on additional proof which can be a lot harder to establish. If there is any possibility...

The best approach to this is to raise the concern directly with the project lead while staying calm. Stating the clear facts and not placing blame is the most important thing that can be done. Bringin...

One of the best ways to avoid the two boss problem, in a matrix organization is to make expectations and priorities clear so that there are no misunderstandings. When the functional manager and the pr...

Working in a matrix can be chaotic especially in medical device companies where QA, R&D, and regulatory all rely on each other but ofter pull in different directions. The structure itself isn't th...

I agree that avoidance is often the way that is preferred in manufacturing because preventing a risk before it happens is the most reliable way to protect both workers and product quality. When avoida...

To put a plan into action, I would focus on using tools and methods that help me stay organized about potential problems. I would start with a detailed risk register so I can track each risk, who its ...

This post brings up an important point about whether the use of FMEA has become too rigid for the reality of modern devices. FMEA is a useful starting tool but it usually fails to capture the unpredic...

Rebuilding a design history file for a legacy combination product can be hard especially when the original documentation isn't finished or does not exist. Since a lot of these products were made befor...

A contract manufacturer plays a important role in process validation by giving documented evidence that the manufacturing equipment, processes, and controls are capable of consistently producing produ...

Even though verification and validation may seem similar, they do serve different purposes. Verification is focused on confirming that the design meets the technical and regulatory requirements. Valid...

The best way to translate a qualitative user need into a testable and quantitive design input is by breaking it down into measurable criteria. To maintain traceability, teams can utilize a design trac...

I think that multiple design reviews should be held throughout the development process. Each stage of design can reveal different issues that might not be able to seen later. Having several reviews he...

I think design controls can actually support innovation when they are utilized in the correct way. Although ISO 13485 and FDA 21 CFR 820 seem rigid, they help teams think through safety, user needs, a...