The Ultimate Guide To Design Controls For Medical Device Startups















What’s this guide about anyway?
Back in 1998, I started my career as a medical device product development engineer.
At that time the FDA Design Controls regulations were still fairly new — not only to me — but the industry in general.
In those days, we all struggled to understand how and what to do with respect to Design Controls.
As my career progressed, I started to understand the purpose and intent regarding Design Controls. But it didn’t happen overnight.
Over the past 17 years, I’ve been fortunate to have played a part in getting 40+ medical devices through FDA clearance as a product development engineer, through my consultancy, and more recently as co-founder of greenlight.guru.
However, for many, Design Control is still a topic that is as confusing today as it was for me many years ago.
With this guide, I plan to share valuable insights to explain what Design Controls are, how to address them, and how they benefit your medical device product development efforts.
You have an idea for a new medical device. Now what?
Congratulations! You have an idea for a new medical device.
Chances are you believe your idea will have a significant impact on the quality of our lives in some way. Chances are your product will help solve some current problem and address unmet needs.
What do you do now?
Throughout the world, there are agencies that govern and regulate medical devices. For example, in the United States, medical devices are regulated by the Food & Drug Administration (FDA).
These regulatory agencies have defined rules and regulations that you and others developing and manufacturing medical devices must follow.
And these regulatory agencies have defined rules and regulations about how medical devices are classified and what is required before the products are sold into the marketplace.
Most notably, since you have an idea that you want to develop further, there are regulations established for you to follow during the product development process. These regulations are known as Design Controls.
This may sound confusing and discouraging. I get that.
And I don’t want you to be confused or discouraged.
This is what drove me to create this “Ultimate Guide to Design Controls for Medical Device Startups.”
In this guide, I will share with you the necessary background about Design Controls from a global regulatory perspective.
I will provide you with knowledge and information that will arm you with more than just the basics.

Some explanation about a Quality System
Yes, I know — this guide is supposed to focus on Design Controls. And it does.
I just need to spend a few minutes explaining what a quality system is and how this relates to your medical device product development efforts.
What is a Quality System?
A medical device company has to establish a quality system.
A quality system is a set of processes and procedures you define and implement to describe how your company addresses medical device regulations, including Design Controls.
FDA defines the rules in 21 CFR Part 820. And if you plan to go to market in the U.S., these regulations are required.
Outside the U.S., Europe requires a quality system be established to meet the medical device directives. Many medical device companies choose to implement a quality system and have it certified to ISO 13485 to satisfy EU needs.
Canada — same thing. The expectation is that a quality system be established. Canada is a little different, requiring you to establish ISO 13485 certification and the Canadian Medical Devices Conformity Assessment System (CMDCAS).
The good news is this… FDA 21 CFR Part 820 and ISO 13485 are very similar. Meaning you can establish a “one size fits all” quality system, encompassing Design Controls too.
Build your Quality System as you go
The quality system expectations is that you have all parts and pieces defined and implemented by the time you go to market.
Yes, there are parts of the FDA regulations and ISO requirements that do apply to you, even if you are pre-market.
If you are going through medical device product development, there are at least 4 parts of a quality system that you need to put in place:
- Design Controls
- Risk Management
- Document Control & Records Management
- Supplier Management
The term I use is “bootstrapping a QMS”. I encourage this approach. Early on, you don’t need to spend too much time implementing a robust quality system. You need to be focused on product development.
And as you get closer and closer to going to market, there are software tools, like greenlight.guru and others, you can use to gradually implement more and more of a QMS.
Just make sure you always keep your quality system in mind from the beginning, so you don’t have to learn how to free yourself from a quality system nightmare down the road.

What are Design Controls?
So far in this ultimate guide, I have spent very little time discussing Design Controls. Yes, this is deliberate.
The stuff I covered so far about understanding medical device product classification and quality systems is very important for you to have some grasp on as you pursue your new medical device idea.
If that information did not discourage you and you are still reading, rest assured.
The rest of this guide is devoted to Design Controls. Really more than just Design Controls.
I will share with you why Design Controls even matter and how they will help you during your medical device product development.
Design Controls — Comparing FDA and ISO
It is important that you design and develop a medical device that is safe. FDA, European Commission, Health Canada, and all other regulatory bodies throughout the world will want some assurances that your medical device is safe before you bring the product to market.
And this is really the essence of Design Controls. Proof that you have designed a safe product that meets user needs and requirements.
Technically speaking “Design Controls” is a FDA term and defined in FDA 21 CFR 820.30 (the 21 CFR stuff is FDA terminology to describe where in the code of federal regulations the topic is addressed).
In ISO 13485 speak, the terminology and intent is similar and covered in section 7.3 Design and Development.
The table below compares the FDA clauses for Design Controls to ISO 13485 clauses regarding Design & Development.

Both FDA Design Controls regulations and ISO 13485 Design & Development requirements expect you to keep documentation and records throughout the product development process.
The Design History File (DHF) is a great place to keep all of your Design Controls “evidence”.
As you can see, there is consistency regarding Design Controls. Although ISO 13485 does not explicitly call for a DHF, it is expected that you maintain records of design and development.
An industry best-practice is to construct a traceability matrix to show the linkages and relationship between User Needs, Design Inputs, Design Outputs, Design Verification, and Design Validation.
Building and maintaining your traceability matrix using tools like Excel or Google Docs a is fairly straightforward task during the early months of product development.
But as your project progresses, you’ll soon find using these general purpose tools often take days, and in some cases weeks, to keep your traceability matrix properly updated and maintained.
This marks a time in your project where switching to a software solution built specifically to meet the unique regulatory needs of a medical device company, like greenlight.guru, can result in significant gains in time to market while reducing risk.