Quality assurance can also make sure Class III devices meet safety standards by focusing on strong documentation and traceability during design and development. Every change and decision should be recorded so that risks can be tracked and then addressed. I was looking up some tools that quality assurance teams use, and I found one called FMEA (Failure Mode and Effects Analysis) which they use to predict problems that might occur and set up controls to prevent them. If you involve quality assurance in the verification and validation testing through the process and not just the end, issues can be caught sooner to make sure the device holds up with the strict Class III regulatory standards. 

In this week’s lesson, we have learned that quality assurance makes sure that all of the systems, structures, reviews, and evaluations meet the requirements to ensure the product or services are approved. Class III medical devices are more high risk compared to Class I and Class II devices, and also require the premarket approval or PMA, which QA must be able to demonstrate that the device is safe and efficient. This would include conducting rigorous testing like clinical testing on humans. They would use the IDE to gather all of this data and try to minimize risk if the device poses a significant risk to users. QA is also responsible for the quality management system or QMS. They have the standard for quality assurance of the ISO 13458 that describes the structure of the QMS as well as give the bare minimum requirements needed to maintain good quality and control for the devices. As the previous users have mentioned, the QA keeps track of the device and development stages by observing the design controls, design process, risk assessment, and post-market surveillance to ensure the device’s safety and efficacy. They have to monitor the entire process from start to finish, and even beyond to monitor the product’s performance towards the target population after a certain amount of time and use throughout the years.

There are many other standards and protocols that QA uses to keep track of the design process and documentation. Class III medical devices are high-risk because these are the types of devices that can be implanted into the human body which includes electrical bone stimulators, growth factors, etc. One of the main standards they use for Class III medical devices is ISO 14971. This standard can be used in the QMS for risk management. It outlines the risk management process for the medical device. It can help identify and minimize any potential hazards that the device holds during different types of testing like clinical testing. This was to integrate the risk management process into the product life cycle. It said that the ISO 14971 was the “backbone” to applying risk management. Risk management is not a one-time thing to look at once the product has been completed or has passed that step. Risk management is to be observed throughout the entirety of the product lifecycle and while it is out on the market. During the design and development stage, this is crucial, as said before, due to these devices posing high-risk being implanted into the human body. One of the new additions to this standard is that the manufacturers need to collect data when it gets to the market and this is for the post-market risk assessment.