A Route to Regulatory Compliance: Part 1: Design Controls

Jul 23, 2019 | Product Development, Quality + Regulatory, Risk Management

Developing a medical device is a complex business, and compliance with regulations and quality requirements is a key component of success.


How would it be, if you had a clear picture of what you need to take care of for these components, what would you do?


In this bite-size video, we’ll take a look at the main things you need to do for your medical device development project, for Regulatory and Quality.  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. In fact, we’re splitting this into two parts, to do the subject justice.


Here’s the route we’re going to follow:

Quality Planning – identifying the requirements you will need to satisfy, including regulations, standards, involvement of notified bodies, verification and validation, and making sure they’re there in your project plan.

QMS – is your Quality Management System (QMS) up to scratch, if you have one; how will the project respect SOPs and processes.

Document Controls – checking that you have adequate and robust control of documentation (both project and routine), as “if it isn’t written down, it didn’t happen”.

All of these are fundamental to any activity, but from now onward, our journey forks – we’ll look at the Quality Management branch line next time. For now, let’s focus our attention on the Design Control branch.

Design inputs – this is the starting point for device design, these requirements are the basis for activities through to validation. That’s why having a solid foundation here is the single most important design activity. It’s tempting to move over this quickly, to get on with making something – yet quality time spent here pays off magnificently later on.

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

Design Documentation – As you embark on developing concepts, document what’s being done, when it happens – this benefits you in so many ways, not least in proving the birth of your IP and giving you solid, reliable information on which to make decisions. It really doesn’t stifle creativity.

Design Outputs – essentially these describe your frozen device design, and let you go ahead with Design Verification and Validation. It’s things like assembly drawings, specifications, test results, risk analyses.

Design Verification – answers the question “have I built my device right”, does it meet the specification.

Design Validation – however, answers a different question, “have I built the right device”, by comparing your device with the needs and intended use you set out to fulfill. Checking if these needs can be fulfilled consistently.

Design Transfer – at some point, you’ll take your device design forward to production. That transfer is what this stop is all about. In reality, it starts at an early stage in development, but comes to its conclusion at this point in your journey. It takes your design outputs and turns them them into production specifications.

Design Changes – from the stop on your journey where you decide to start design controls, you’ll be taking care to identify, document, assess and manage changes to the design as you go, usually in line with a procedure or process.

Regulatory Authority approval – before you can sell your new product, you’ll need to get approval from national authorities.  As we mentioned before, this is where you set out the story of your medical device for regulators to review, ask questions, and hopefully approve for sale. Don’t underestimate the time this step can take.

Change Management – doesn’t stop just because you’re on the market, keep on identifying, documenting, assessing and managing changes, particularly in light of post-market surveillance data.

QMS Update – alongside this, your QMS should evolve to respond to changes in regulations, the way you work as a business and what your competitors are doing.

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.


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