People may choose to participate in clinical trials for a variety of reasons. Some may have a personal health condition that lacks effective treatment...

From a statistical perspective, ensuring diverse representation in clinical trials is crucial for enhancing the validity and generalizability of the r...

This SWOT analysis changes if the company was based outside of the US (taking a UK-based company for example). Strengths: Innovative Produc...

A recent example of an external environment factor affecting companies is the CrowdStrike incident earlier this year. This was a major external event ...

With the growing role of technology and engineering in medical device development, marketing strategies must evolve to effectively communicate value t...

The two U.S.-based companies I reviewed are Zimmer Biomet Holdings, Inc. and Integra LifeSciences Corporation. They both supply surgical medical devic...

Another key component of building a business is creating a strong marketing strategy. Knowing your target audience and understanding the demographics ...

One key element of a quality system that directly impacts the safety and efficacy of medical devices is the inspections conducted during the productio...

Building on this discussion, it's essential to recognize that quality assurance (QA) has to prepare for both internal and external audits. The prim...

Finding a way to harmonize submissions in the biopharmaceutical industry is a challenge due to the varying requirements of regulatory agencies. In my ...

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

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 he...