Regulatory Affairs is a great field to explore. From my own industry experience and from speaking with hiring managers, there is always a high need for employees knowledgeable about the regulatory process. I’ve personally been involved in a few Corrective…   Read more»

I think post-market management may have a more significant long-term impact compared to product development. While both play important roles in projects, the main focus of product development is meeting regulatory standards and checking device safety and efficacy. While this…   Read more»

You did a great job summarizing the FDA and CDRH’s role in regulating medical devices. It is also worth mentioning that the approval process for Class II and III devices is much more involved because of their higher associated risks….   Read more»

Filing with multiple international agencies is a complex process. Harmonizing regulatory submissions across different countries is challenging, but can be aided through strategy and planning. Many companies develop a global regulatory strategy, including input from regulatory teams from each country,…   Read more»

While I do agree that regulatory consultants can be helpful in staying up to date with changes from the FDA and ensuring compliance, I would argue that some companies take an alternative, often more stable, route. Full-on regulatory groups are…   Read more»

Most responses in this discussion bring up using other avenues to conduct clinical trials such as artificial tissues or bioreactors. While these are amazing innovations that may lead to a reduction in animal testing trials, there is already a system…   Read more»

Stability testing is certainly imperative for specific applications in the medical field. One specific product that I have not seen mentioned is sutures! From my personal experience working with a company producing sutures, stability testing is vital when moving from…   Read more»

I certainly agree that when the project manager or PI is organized accomplishing tasks/projects becomes easier. Project managers who are on top of the people who report to them, and the actual projects, definitely make project timelines smoother and easier…   Read more»

I’m not a project manager just yet, but I have seen the stress that comes with the role of a project manager. I’ve been involved in a CAPA where multiple job positions were opened up to address inconsistencies in findings…   Read more»

During my time in industry, I’ve noticed the necessity of time management in terms of project efficiency and effectiveness. I think this question is fundamental to consider, particularly if you plan on working in a project-based role. For me, it…   Read more»

The majority of replies that I have read on this forum revolve around the importance of high GPAs losing their merit in today’s day and age. While I do agree with these statements in *some* cases, when trying to rise…   Read more»

Taking a medical device from its conception to delivering the device to patients is an area that I have recently become more and more interested in. I first chose BME as a major during my undergraduate studies as I was…   Read more»