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 discredit the witness on anything so as to prove their statement may not be trust worthy. Even if the witness is completely clean and trustworthy, theres no…[Read more]

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 most out of every situation. The company that sent the part of course was going to try and get as much money out of the mistake as possible, but there…[Read more]

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 violated further solidify the importance.
In the article hmp42 posted, Health Alliance of Greater Cincinnati and The Christ Hospital in Ohio, were…[Read more]

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 a concentration much too high for the patient on the table, that could be problematic. All of the staff know how to implement the stent, but if that…[Read more]

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 your bodies’ functions to break it down and utilize it effectively. There, the efficacy and risk of a drug is based solely on how it interacts with…[Read more]

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 acceptable for risk management processes. There are many topics covered in this document, but overall I believe it is useful for identifying your…[Read more]

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 that are essentially only to be used by other companies, not themselves. If you want to be compliant with a certain agency, it is a smart business…[Read more]

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 that the inputs are based on the end users needs, but aren’t simply a list of the end users needs. For example, if you are going to be developing a new…[Read more]