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 can only be represented to a certain point before reaching into the “grey area” in terms of the product having human risk. Previously mentioned,…[Read more]

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 are created, a placebo, blind and a controlled to name a few, each that patients are selected through randomization. In addition, another reason that…[Read more]

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; which is CAPA. In addition as mentioned, correction is an immediate action that receives full attention that is a short term solution while the…[Read more]

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 findings discovered from our field technicians that provided technical support to our clients. Once this issue was discovered, we documented the number…[Read more]

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 grandfathered into a new product, if and only if, the product is closely similar to the predicate. As an example, device A and device B, device B is the second…[Read more]

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 solution, the ambiguity can cause internal debate depending how the individual interprets the general requirements. Having the GMP’s vague is to allow…[Read more]

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 projects unless there is substantial request for such a product from the general market. Indeed there are some companies that takes risks on funding…[Read more]

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 engineering team, a problem which was identified to causing interference. Once the problem was identified and verified, the SOPs for this process was…[Read more]

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 these sections holds substantial significance in the product’s life cycle. The Discovery and Innovation is best in identifying the market, customer needs,…[Read more]

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 conducted to identify the problem, perform a preventative maintenance and get the equipment fixed and properly calibrated according to the SOP’s for this…[Read more]

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 aspect of the validation process become more complicated which would require a verification process to go along with it. The validation procedure ensures…[Read more]

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 delivery device manufacturing line.

Syringe Filling Process:

IQ: Since the medical device is mechanically operated. the IQ would test the device if…[Read more]

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 do to run certain tests step-by-step to achieve certain results or outcomes. SOPs are approved by the author, SOPs are needed in Design Controls and…[Read more]

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 of money to actually process, initially all departments associated with the design controls must agree on the reason behind the request. Personally i…[Read more]

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 device failure. Post market surveillance is necessary to keep track of consumer feedback, possible issues of the device, provide market research comparing…[Read more]

Verification = Inputs = Outputs
Verification is completed after DAD and RA, this document shows the tests that were created for each specification or requirement in the DSD to verify that the design input meets the needs of the design outputs. This document will have a protocol on how the the test plan for each requirement is setup and the report…[Read more]

From my experience in working in the industry, the DHF i believe should be a living document along with the DMR. I can understand that the DHF is a history of the initial design history, SOP’s, and design control documents such as DID, DSD and PDF along with the Validation and Verification protocols and reports. In the company that I work for…[Read more]

Essentially MEDDEV, NB-MED, and Competent Authority Guidance Documents all have their uses and advantages. However, considering the process of NB-MED bring written by notified bodies and MEDDEV written by competent authorities and lastly competent authority guidance documents written by individual CA’s, NB-MED would be the most useful. NB-MED has…[Read more]

As mentioned be other fellow commentators, combinational medical device are much difficult to classify for those in the Notified Bodies, this is because according to the directives, the device would fall under either of the three categories, MDD, IVDD, and AIMDD. I currently do not have experience with comdinational medical devices but from what i…[Read more]