Validation at its core is the process of making sure an item, programme or piece of software works in the way that it was intended to. In the case of medical device validation, this is a vital process to ensure that each device is safe for patient use and will function correctly for each patient without room for error and potential to harm.
The US FDA defines validation in the following way: “Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.”
Validation vs verification
To break this down into something easy to understand, think about an item of flat pack furniture. The design itself will have been verified to make sure that it contains all the parts necessary to make a wardrobe, table or bed. Once you purchase it however, it’s down to you to follow the instructions and assemble it. Depending on your DIY skill, or level of patience in some cases, the end results may not always be the same.
Imagine you were prescribed with an asthma inhaler. You would want to ensure that the inhaler works correctly, that it’s going to deliver your medicine accurately each time and that there is no danger in using it.
This is where design verification and validation come in. Design validation refers to the creation of the device, whereas process validation looks at all processes involved in manufacturing it, including the use of a quality management system. Each and every step that is taken to manufacture the asthma inhaler has been checked, tested and validated, including every piece of equipment and software involved in the process. This could be everything from a ruler to the computer where data is entered, and the software used to manage quality.
During the validation process, everything is not only tested, but the results are recorded. This gives assurance to people such as the doctor prescribing your inhaler that it not only works correctly, but it is safe. It’s assuring them that the inhaler contains the correct medicine for treating asthma in the right dosage, and it will administer it properly.
What’s involved in validation?
Imagine you’ve just got home from Ikea. Your friend has recently moved into a new apartment and they are looking to buy the same bed as you but first, they want to know how easy it is to build and whether it is comfortable - you’re basically the guinea pig in this situation. Before you do anything, you need to make sure that you’ve got the space to put the bed together, the correct tools and the physical capacity to undertake the required actions. You also need to be able to follow the instructions carefully and accurately to make sure the end result is the same bed that you saw displayed in the store.
Why is this important for medical devices?
A poorly constructed bed isn’t the end of the world. You can always disassemble it and start again or turn to a more DIY savvy friend for help. People’s lives and their health rely on medical devices however, so there is no room for error.
Let’s go back to our asthma inhaler example. There are several parts to the device: the canister, plaster holder, propellant, metering valve, mouthpiece, mouthpiece cover, aerosol and the medicine itself. The process of creating each individual component needs to be validated, as does the process of putting them together to ensure that each inhaler is of the same quality and consistently delivers a precise dose of medication in the way it’s supposed to.
Medical device software validation
The new EU Medical Device Regulation (MDR) which comes into effect on the 26th May 2020, stipulates that medical device manufacturers must have an established Quality Management System in place in order to sell within the EU. Having a QMS also helps to achieve and maintain compliance with FDA’s 21 CFR 820 and Part 11, ISO 13485 and ISO 14971. We now offer software validation in partnership with CompliancePath, who specialise in validating software for use in life sciences.
William Coupe
William has spent more than 16 years working with GRC software applications, acting as a trusted advisor for some of the worlds largest organisations, spending many years in the product management and pre-sales of eQMS software applications.
He now uses that knowledge to ensure the customer gets it right first time when deciding on a system.
In his free time, he’s often running up fells and can be found near the back in most races.