Why is it important to consider the hazards and hazardous situations as aspects to be evaluated separately? In biomedical devices, hazards are potential dangers, such as exposed electrical components ...

Risk management is not only crucial in medical devices where patient safety is a top priority or not only ensures compliance with regulations such as ISO 14971 but at the same time, it is also importa...

I completely agree that proper training is critical to avoid mistakes with biohazard protocols. For example, take the case of a newcomer in a biology lab who is assigned to sterilize re-useable pipett...

I agree, after learning about verification and validation this week, I've gained so much knowledge about the safety and reliability of the medical devices we use. It definitely makes me feel much more...

Customer feedback is a very critical part of the design input process, yet sometimes difficult to gather and put into concrete design specifications. How do design teams prioritize customer feedback i...

While verification ensures that the design meets the specifications, and validation ensures it meets the user needs, there can be times when these two processes will run into each other and overlap. D...

Design control is a sensitive and important task in medical device manufacturing companies. The protocol to undergo design control and review can be considered a milestone in meeting regulatory norms ...

Enhanced Data Security and Patient Privacy: Likewise FDA, medical companies have to follow HIPAA regulations. If the device is connected to a software operation, software validation protects the pati...

Medical device manufacturing companies have more crucial and sensitive responsibilities than other corporate sectors. Medical devices have a direct impact on the health and wellness of society. Despit...

What ethical issues come up when using artificial intelligence (AI) in clinical trials, especially regarding how participants are chosen, how data is analyzed, and keeping patient information private?...

Payment gives recognition to the participants' time and risks, which enhances the recruitment process, and boosts diversity. On the other hand, ethical concerns regarding coercion arise. Financial inc...

A double-blind study design is crucial in clinical trials to eliminate biases that can distort results. The fact that a single-blind study reduces participant bias does not account for the influence o...

In healthcare, where there are many strict rules and regulations. For doctors, providing clear evidence-based data on safety and effectiveness is key. Patients need easy-to-understand communication th...

I would say, product development focuses on creating new products through research and innovation and mainly turning ideas into real solutions or prototypes that meet one's customer needs. On the othe...

I agree that sales and marketing are fantastic fields for people who enjoy working with people. Although I haven't directly worked in these areas, I see how essential they are for any business. market...