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 ...

Grzegorz Galka I think your example raises a very relevant, interesting real world example to settling disputes outside of a court. I think many compa...

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...

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...

I think the major differences in risk management with medical devices and pharmaceuticals comes down to the mode of action. Pharmaceuticals (in many c...

The ISO 14971 regulation lays out an entire risk management framework for medical devices. Regardless of what country you are manufacturing your devic...

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 numbe...

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 d...