In the world of biomedical engineering, regulatory agencies like the FDA (Food and Drug Administration) in the U.S. and EMA (European Medicines Agency) in Europe play a critical role. These agencies e...

The two U.S.-based companies I reviewed are Zimmer Biomet Holdings, Inc. and Integra LifeSciences Corporation. They both supply surgical medical devices for spine and orthopedic conditions on the mark...

Another key component of building a business is creating a strong marketing strategy. Knowing your target audience and understanding the demographics you are selling to is critical for positioning you...

I know and have experienced the transition from paper-based systems or between integrated Enterprise Resource Planning (ERP) and Quality Management Systems (QMS) in companies. At one company they tran...

One key element of a quality system that directly impacts the safety and efficacy of medical devices is the inspections conducted during the production process, particularly the final inspection. Insp...

Building on this discussion, it's essential to recognize that quality assurance (QA) has to prepare for both internal and external audits. The primary purpose of internal audits is to assess whether ...

Finding a way to harmonize submissions in the biopharmaceutical industry is a challenge due to the varying requirements of regulatory agencies. In my experience, companies typically build a general te...

EUDAMED (European Database on Medical Devices) is an IT system created by the European Commission under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR)...

In response to your question, the FDA's approach to minor errors in compliance during an audit depends on the severity and potential risk to public health. When reviewing an audit, the FDA categorizes...

In pre-clinical development and research, are there differences in regulations between industry and academic research? I can see companies having more rigorous regulatory standards from regulatory age...

I agree that the complex and rigorous regulatory process of medical device development is difficult for companies to navigate. This is where regulatory consultants can play a crucial role in navigatin...

As many mentioned, it’s clear that there are significant differences between academia and industry research, particularly in terms of how they use their skills in each field. However, I also think the...

In fields like biomedical engineering, while deep technical expertise may not be mandatory, having foundational knowledge is crucial for understanding the complexities of projects and managing teams e...

I agree with many of the points made about the role of project managers and their need for strong communication and social skills. In my view, effective project management hinges on a few key abilitie...

In the medical device industry, beginning certain aspects of execution during the initiation phase can be crucial, particularly for preliminary testing and development. In the medical device industry,...