A route to Regulatory Compliance: Part 2 – Quality Management

Jul 30, 2019 | Product Development, Qualification & Validation, Quality + Regulatory, Risk Management

Compliance with regulations and quality requirements is a key component of success when you’re developing a medical device.

If you had a good feel for what you need to take care of for this, what would you do?


In this bite-size video, we’ll continue our exploration of the main parts of Regulatory and Quality throughout the life of your medical device

The time we have doesn’t allow us to go into too much detail, so do get in touch if you’d like to go deeper.

You remember that last time, our journey forked part way along the track, to look at Design Controls?

This time we’ll look at the Quality Management branch.

Design Review (search for our video “4 w’s of Design Review” to learn more about these)

Purchasing Controls – yep, it’s required by FDA, and others, that you have control over what is bought, from whom and to what requirement. That’s what this is about, having a process to do all that, especially the more critical the thing or service you’re buying

Supplier Evaluation – again, particularly for the more critical things, you need to demonstrate you’ve followed a process to identify, evaluate, select and manage your suppliers.

Design Qualification – sets out to answer “does the design I’ve come up with meet the Design Inputs we’ve written down” (we spoke about these in the previous part)

Test Methods – it’s no good testing devices without using a documented method, as how else can you have confidence in the results? That’s what this stop is all about, creating, refining and validating test methods – they can be for incoming materials, in-process checks, product release, development tests.

Installation Qualification – when you’re putting in new or changed equipment, its installation needs to be qualified, to confirm what you’ve put in is what you wanted it to be.

Operation Qualification – then, you’ll confirm that the new or changed equipment actually functions like you wanted it to.

Process Verification – going a step further, you need to demonstrate that the process that uses this equipment works as you expected.

Performance Qualification – then, you will check that this process really does perform as you wanted, over time, reliably and consistently.

Validation Reporting – all of these activities are wrapped up in reporting, which also concludes on whether you have really made the right device.

Supplier Quality – builds upon the Purchasing Controls and Supplier Evaluation stops, to make sure that you continue to get what you need for the devices you produce to be safe and effective in use.

And from here on, we come back together with the other track as your product gets launched.


As you watched this video, you’ll have started to think about how you can be making best use of this information. You may now want to get some guidance on how to go about it more effectively.


Now that we’re coming to the close of this video, subscribe to our YouTube channel, or follow us on social media (the links are just below), so you’re the first to know when new content is available.

Thanks for watching, remember to send us your feedback and comments.