- Redirection of Root Cause Analysis old page
This page has been moved…https://medicaldeviceacademy.com/root-cause-analysis/ … - 5 Tools for Root Cause Analysis and How to Perform a CAPA Effectiveness Check Webinars
5 Tools for Conducting Root Cause Analysis – Free Webinar and PowerPoint Download “You cannot plan corrective actions if you don’t know what the root cause is.” –Rob Packard, Founder, Medical Device Academy This webinar includes information on – Key elements… - Root cause analysis – Learn 4 tools
The author describes four tools (Five Why Analysis, Is/Is Not Analysis, Fishbone Diagram, and Pareto Analysis) and how each one can help conduct effective root cause analysis. Quality problems are like weeds. If you don’t pull them out by the root, they grow right back. Training on the 4 Tools Mo… - ISO 13485 – need training?
Learn how to become ISO 13485 certified while avoiding the stress that tortures other quality system managers. Your cart is empty What is ISO 13485? ISO 13485 is an international standard for quality management systems that is specific to the medical device industry. ISO 13485:2016 is the most r… - How long does it take FDA to review De Novo submissions?
The new FDA goal is to review De Novo submissions within 150 days for 70% of De Novo submissions, but how long does it take now? What is an FDA De Novo submission? An FDA De Novo submission is an application submitted to the FDA for creating a new device product classification. There are three clas… - CAPA procedure, How do you improve quality and prevent nonconformity?
Your CAPA procedure is the most important SOP. It forces you to investigate quality problems and take actions to prevent nonconformity. Your cart is empty CAUTION: Read the story in the next few paragraphs before you implement any purchased procedure During a recent internal audit, I noticed th… - What is a CAPA Board? and Do you need one?
A CAPA Board is a team responsible for making sure that all CAPAs are completed on time and the actions taken are effective. Many of the medical device companies we work with have to open a CAPA for their CAPA process because they fail to implement all the actions that were planned, they fail to im… - Is monitoring every procedure required?
Process monitoring is required but do you know whether monitoring every procedure is required by the FDA QSR or ISO 13485? One of the elements that Medical Device Academy has incorporated into each procedure we created in our turnkey quality system is a section titled, “monitoring and measurement… - Testimonials
Below is a collection of testimonials from a few of our clients whom we have provided training and consulting services for over the years. Testimonials “While searching for guidance on how to validate an IFU, I came across the webinar on ‘IFU Validation and PMS’ sponsored by Medica… - Human factors process, can we make this easy to understand?
90% of usability testing submitted to the FDA is unacceptable and the root cause is simply a failure to understand the human factors process. If you submitted no usability testing to the FDA in your 510(k) submission, it would be obvious why the FDA reviewer identified usability as a major deficien…
