I highly agree with this sentiment. Corporate culture can change in the blink of an eye. I too share the same experience where shuffling management has resulted in a drastic change of perceived job security and camaraderie. However, the amount of completed CAPAs and NCRs were up, as were bonuses. It is certainly interesting to say the least.…[Read more]

Usually the quality management system establishes the guidelines to periodically perform a risk assessment. This risk assessment is performed by people who are qualified to perform such activities; an engineer familiar with the device, a quality representative that performs CAPAs and NCRs on said device, and someone from the complaints department…[Read more]

This is a great discussion topic! I believe many of the failures in risk assessment can come from a lack of resources within the company. By resources I mean information and or the personnel required to adequately provide an honest assessment to the medical device. An example would be a poorly managed complaints department at a medical device…[Read more]

As already discussed by others, the best ways are a quality system supported DFMEA matrix, collecting information from various sources such as the complaints department and the past quarter’s CAPAs and NCRs, SWOT analysis and others. I believe the best way on handling the risk identification is to periodically update the assessments every other…[Read more]

I believe that Gantt charts are great to keep you in focus with what your deliverables, milestones and project scope should be. In my industry experience, I’ve used Gantt charts to address CAPAs and NCRs. The CAPAs would require a due date set by corporate and you would plan accordingly so that you don’t get stuck with a few headaches down the…[Read more]

Roberto this is an excellent topic of discussion and as you will find in the field, often a topic of contention. The FDA provides guidelines on how tests should be executed. Take a look at the recent changes to the guidelines for LAL testing and you will see that the FDA does not claim specifics. Another example would be the guidelines to…[Read more]

Even though the lecture cited examples, I would sleep easier knowing validations were done to mitigate risk. Even if there were no changes affecting the human factors of the device, you still need to check the product. What if there are no changes but suddenly an outside factor such as out of control bioburden affects your product? The validations…[Read more]

Design verification is part of the quality control system where documents, resources, specifications, equipment installation and associated operation & performance qualifications, vendor qualifications and re-qualifications, etc. Verification is part of the quality management system and ensures that the resources utilized in making a medical…[Read more]

Design controls of a medical device covers the design plan, the design itself, the outputs to meet the required design inputs, the design validation and the DHF. It is an important aspect in the design of a new medical device as it ensures that the medical device is capable of performing its intended purpose.
It is a method of controlling and…[Read more]

Lamiaa:

Designs controls, in my opinion, is the most important thing a medical device manufacturer needs to get right. Could you imagine working for a company that never implemented the proper design controls for their product? I recall once working for a company where any change you wanted to push down the line was stonewalled by other…[Read more]