As the previous commentator mentioned previously, it is difficult to predict adverse effects of a product using collected data from pre-clinical trials. Indeed, pre-clinical trials holds value but it ...

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 doctors conducting the tests. Several trial groups ar...

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 actively prevent the nonconformity from occurring;...

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 team. In addition, this finding matched with the fi...

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 documents from previous product can be grandfathe...

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 problematic in terms of having departments agree on a solut...

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 generally very cautious about funding new innovative ...

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 analysis based on a problem identified from our engine...

In a product's life cycle as we all know consists of the following: Discovery and Innovation -> New Product Planning -> New Product Introduction -> Post-Launch Product Management. Each of the...

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 ineffectiveness, a root cause analysis would need to be conduct...

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 depends on the wording, this would make certain aspe...

I would agree with many that have commented in regards to the syringe filling process, vascular weaving line, antibiotic releasing hip stem manufacturing line, and wound healing growth factor and deli...

SOP's are standard operation procedures, this is included on all realms of QA, manufacturing, clinical/non clinical testing etc. SOPs is the document that describes what a trained individual needs to ...

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 are completed. ECO's generally cost a large amount ...

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 initiate to keep track of any complaints or devic...