A standardized dispute resolution mechanism like mandatory arbitration could streamline international business dealings by providing a consistent framework, regardless of varying legal systems. It wou...

An NDA and a patent serve different purposes: an NDA protects confidential information shared with others, while a patent grants exclusive rights to an invention, preventing others from using it witho...

Great questions! While "verbal agreement" and "oral agreement" are often used interchangeably, both refer to spoken agreements rather than written ones. However, relying solely on them can be risky du...

Software validation ensures that device software functions reliably and meets high-quality standards. Beyond the obvious benefits like decreased failure rates and fewer recalls, it also brings other l...

Yes, understanding validation and verification gives me a lot more confidence in the safety of medical devices. Knowing that these processes are in place means that devices are rigorously checked not ...

To answer this question, verification and validation (V&V) can be conducted simultaneously in some instances, especially with iterative or agile development, which can save time and improve feedba...

To answer this question, factors influencing how a company interprets these guidelines often include company size and resources. The most important one is Company Size. Smaller companies with fewer re...

Hey everyone, I was going through the lecture on Design Controls and had some thoughts. What do you guys think about the purpose of Design Controls under FDA's 21 CFR Part 820.30? How do you see each ...

In the medical device industry, audits ensure compliance with regulatory standards. They can come from customers, bodies like the FDA or BSI, or internal teams. When I participated in an audit, I help...

To answer the first question: A glucose monitoring device exemplifies each category well. Functionally, it should measure blood glucose within an accurate range. In terms of performance, it needs to d...

Interesting topic. Businesses retain customers by offering personalized experiences, loyalty programs, and proactive support. CRM systems help track interactions and automate follow-ups, boosting long...

Personally, I would want to be part of a Limited Liability Company (LLC). The big advantage of an LLC is that it provides liability protection, meaning my personal assets wouldn’t be at risk if the bu...

For the first question, In my view, if someone has a sole proprietorship and wants to pass it on to their two sons as the business grows, they'd need to make some structural changes. You can’t transfe...

Interesting question. Clinical trials are crucial to getting both medicines and medical devices approved. However, when it comes to medical devices, the trials can vary greatly depending on the device...

The FDA's strict regulations play a significant role in keeping us safe, but sometimes they slow down innovation. The lengthy approval process helps prevent dangerous or ineffective products from bein...