As the previous commentator mentioned previously, it is difficult to predict adverse effects of a product using collected data from pre-clinical trial...
During Clinical Trials there is always the potential of risk. such as immediate biasing in the trial groups from either the patients or the actual doc...
As mentioned by many above, correction is the actual action to eliminate the nonconformity, on the other hand the corrective action is the process to ...
In my experience with nonconformance with one of our products, it was related to an issue that was identified through receiving feedback from our QC t...
In my opinion, and as mentioned prior by some of the users, this situation is handled differently case-by-case. There are only certain situations when...
Indeed the ambiguity of GMP's pose an issue with start-up companies that do not have a good foundation in a quality system. Ambiguity can be problemat...
Based out of my experience in the current company i am part of, is the funding as well just as the fellow user mentioned prior. Some companies are gen...
From work experience, I have not encountered a product failure in the current company that I am apart of, but I have participated in a root cause anal...
In a product's life cycle as we all know consists of the following: Discovery and Innovation -> New Product Planning -> New Product Introduction...
Just how it is mentioned by many prior in this discussion thread, if the equipment in the manufacturing plant is damaged to the point of ineffectivene...
As previously mentioned by the fellow commentators, both the FDA and ISO requires a form of validation for medical devices. That being said, it all de...
I would agree with many that have commented in regards to the syringe filling process, vascular weaving line, antibiotic releasing hip stem manufactur...
SOP's are standard operation procedures, this is included on all realms of QA, manufacturing, clinical/non clinical testing etc. SOPs is the document ...
ECOs are used to make changes to the device if the SOP's , suppliers, processes have been changed. ECO's are set into place once the design controls a...
For medical devices class II and class III are required to have post market surveillance. This is a required procedure for medical device companies to...