Anthony you pose a great question here. I personally don't think that a witness in court is enough to back up a spoken agreement with confidence. The opposing counsel will try their hardest to discred...

Grzegorz Galka I think your example raises a very relevant, interesting real world example to settling disputes outside of a court. I think many companies, and people for that matter, try to get the m...

The link that hmp42 posted is very interesting and worth the quick read. I think it's great to know what the acts mean and why they are important, but I think the real world examples of how they were ...

While yes, everyone should obviously be trained properly ahead of time, this doesn't mean that mistakes don't happen. For instance, if for some reason someone grabbed a drug eluting stent that elutes ...

I think the major differences in risk management with medical devices and pharmaceuticals comes down to the mode of action. Pharmaceuticals (in many cases) are chemically based and therefore rely on y...

The ISO 14971 regulation lays out an entire risk management framework for medical devices. Regardless of what country you are manufacturing your devices in, they all view this ISO guideline as accepta...

I think the major reason that these Regulatory Agencies make companies pay for the regulations is simply a matter of business. They spend a huge number of man hours to develop all of these regulations...

Design inputs ensure that your design requirements correspond with the intended use of the device, with a strong focus on the end users needs. After doing some research on design inputs, I've found th...