Design Controls for Medical Devices

Design Controls indicate that the medical devices your company makes are both safe and efficacious for the end-users.

Let us say that your R&D department has come with a brilliant idea for a knee implant that will eliminate the disadvantages of currently available models. Now, you need to assure international regulatory agencies that your medical device will serve its purpose, is safe and efficacious before you market it.

This is the crux of Design Controls.

You are proving to the concerned authorities that the knee implant your company has designed is a safe product that will meet all the needs and prerequisites of the end-user.

In this article, we will be discussing the following subtopics:

• What Are Design Controls?
• Do You Need to Develop Your Product Under Design Controls?
• What Are the Standards and Regulations Governing Design Controls?
• What Are the Different Design Control Phases?
• What Is Design History File (DHF)?
• How Does QMS Software Improve the Medical Device Design Control Process?
• Frequently Asked Questions About Design Controls

What are Design Controls?

Regulatory agencies across the globe want assurances that the medical devices your company produces are safe and efficacious. You must be able to prove that your medical devices meet end-user needs and requirements. As mentioned before, this is the essence of Design Controls.

Let us revisit the knee implant designed by your company. You now need to prove to regulatory agencies that it will serve its purpose, is safe and efficacious through Design Controls.

Do You Need to Develop Your Product Under Design Controls?

First of all, you will need to check whether your planned medical device needs Design Controls.

All Class II and Class III medical devices need to be brought under Design Controls. This means that X-ray machines, surgical needles, implantable medical devices (for instance, your planned knee implant) are amongst the medical devices that come under Design Controls.

We know that 47% of all medical devices come under Class I. These are low-risk products that include:

• Bedpans
• Crutches
• Canes
• Bandages
• Braces
• Etc.

Most of these devices are exempt from Design Controls.

Learn more about FDA medical device classification in our dedicated article.

In case you doubt whether your medical device comes under Design Controls, you should contact a medical device consultant who will go through the requirements that apply to your particular situation.

What Are the Standards and Regulations Governing Design Controls?

Some of the applicable regulations and standards that govern Design Controls are:

FDA 21 CFR Part 820.30

Design Controls is a term defined by the FDA 21 CFR 820.30.

These are a set of regulations that the FDA has set out for current good manufacturing practices (cGMP) to be followed by medical device manufacturers in the United States.

ISO 13485:2016

The ISO 13485:2016 standard specifies requirements for a quality management system (QMS) when a medical device manufacturer needs to demonstrate their ability to provide medical devices and related services that will meet customer and applicable regulatory requirements.

The following table compares the relevant clauses under the FDA 21 CFR 820.30 to ones under the ISO 13485:2016.

As you can see from the table, the relevant subsections of FDA 820.30 such as (a) General, (b) Design and development planning, etc. have comparable subsections under ISO 13485:2016.

This also means that you will have to maintain a lot many documents and records about a single medical device.

Additionally, you might be faced with the challenges of getting the signatures of the requisite staff, tracking all these documents circulating between various departments of your organization. To avoid all these hassles, nowadays medical device manufacturers prefer QMS software, designed for medical device companies.

What Are the Different Design Control Phases?

Let’s imagine that you have determined that the new knee implant you are planning to bring to the market needs Design Controls.

So, let us, now, look at the nitty-gritty of the design control process.

The 9 different design control phases are the following.

1. User Needs Phase

The user needs phase is the first step of designs control. Your team will need to identify and establish the intended use and indications for use of the proposed medical device.

The intended use of the new medical device is the objective. This means the general purpose of the device.

On the other hand, indications for use should describe the disease and/or the conditions that the proposed medical device will diagnose, prevent, cure, or mitigate.

During this phase, you will also need to define the potential patient population for which your medical device is indicated.

2. Design and Development Planning Phase

The next step in Design Controls is the design and development planning phase.

To start this process of Design Controls, your team will have to establish a plan that will illustrate design and development activities, highlight the responsibilities for implementing the plan, and include the protocols for reviewing, documenting, updating, and approving plans as this phase progresses.

Let us look at what the regulatory authorities state about this design control phase.

The FDA 21 CFR 820.30 defines the Design and Development Planning phase in subsection (b) as the following:

“Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process.”

The ISO 13485:2016 7.3.2 defines the Design and Development Planning phase as the following:

“The organization shall plan and control the design and development of a product. As appropriate, design and development planning documents shall be maintained and updated as the design and development progresses.”

3. Design Input Phase

During this phase of Design Controls, your team will need to describe the exact specifications of your proposed medical device. You will need to emphasize what the device will do and how it will perform.

Let us look at the new knee implant that your company is planning to manufacture. The intended use is to restore function in severely diseased knee joints and mitigate the pain. Its performance should be superior to the currently available products in the market.

4. Design Output Phase

During this phase of Design Controls, your team will document the exact specifications of the new medical device.

What are the intended materials and components needed to build the new device?

Questions like the one above are answered during the design output phase.

As you develop design outputs, you will need to show their relationship to design inputs (Phase 3) with a Design Controls Traceability Matrix. The relationships between Design Inputs and Design Outputs can be done in Microsoft Excel. This is possible at the beginning of the product development phase. However, do remember that later, this can become rather complex.

Another point to be remembered during the Design Output Phase is that you should establish the Device Master Record (DMR).

The DMR will contain all the information and specifications that you need to manufacture a medical device from start to finish. It will also include instructions for the complete manufacturing processes, drawings, specifications, and labeling and packaging requirements.

5. Design Review Phase

During the process of Design Controls, your team will need to conduct formal design reviews and validate them. During these stages of Design Review, you will get the opportunity to evaluate the design requirements of your new medical device. You will be able to ensure that your device is on track.

Let us look at the example of your novel knee implant. With a variety of experts on board, you will ensure that all specifications are met and there are no glitches.

6. Design Verification Phase

During this phase of Design Controls, your team will test the new medical device in a variety of ways to make sure that it has been developed properly.

To put it succinctly, you are ensuring that your medical device is working as intended.

Taking the example of the novel knee implant, you are ensuring during this phase that it is actually doing its job!

7. Design Validation Phase

This phase means that your medical device conforms to the needs of the user and its intended use. Design validation is performed using initial production units, batches, or lots, and not on prototypes.

The question “Did we develop the correct device?” is answered during this phase.

8. Design Transfer Phase

During this phase of Design Controls, you will actually start the production of your medical device.

You must ensure that the complete details of the design are transferred correctly to the production team so that the medical device is manufactured without any hindrances or obstacles.

Looking at the example of the new knee implant, you will ensure that during the design transfer phase, the product is manufactured according to specifications.

9. Design Changes Phase

If there are any revisions to the original design of a medical device, the Design Changes Phase comes into play.

Let’s say that you need to make some adjustments in the manufacture of your novel knee implant. This is possible through proper document control and change control during the Design Changes Phase.

It might be that you are struggling with the management of your existing document control and change control tasks. QMS software with built-in document control and change control capabilities can help you to automate reoccurring tasks such as data collection, routing, follow-ups, notifications, approvals, and much more. This basically means that all change control of documents and product changes can be managed with an integrated Quality Management System (QMS) software solution.

What is Design History File (DHF)?

All documentation about Design Controls should be compiled in a master file labeled as Design History File (DHF).

The Design History File (DHF) will not only show all steps taken during the development of your new medical device but also detail the links between the various phases of Design Controls. This is a mandatory requirement for regulatory agencies (such as FDA 21 CFR 820 and ISO 13485:2016) worldwide.

The creation of the DHF is typically the last step or phase in the Design Control process.

When you have efficient and reliable eQMS software such as SimplerQMS, you will find it much simpler to compile your DHF and to have it ready for audits and inspections.

Let us look at one such utility of the SimplerQMS design control software module, namely, the Document Collection feature. With such a solution, you can easily make a ‘snapshot’ of all current documentation for every product in your company. Subsequently, you will be able to export the required documentation or share it with relevant external agencies. This means that you will not have to waste any time searching for the required documentation when compiling your DHF, DMR, or TF.

How Does QMS Software Improve the Medical Device Design Control Process?

If your company is still reliant on manual paper-based systems for managing your DHF for every product in production, you would have realized that this is very time and labor-intensive and often leads to the following errors:

• Missing documents and records 
• Missing signatures for document reviews and approvals
• Disconnected processes and decreased traceability
• Other challenges…

You can easily eliminate these problems by implementing QMS software at the very beginning of your product development cycle.

Cloud-based Quality Management Software such as SimplerQMS is specifically designed to help organizations such as yours to accelerate market access by streamlining design control, and many other quality processes.

Frequently Asked Questions About Design Controls

Final Thoughts

Design Controls ensure that the medical device that your company is launching is safe, efficacious, and intended for its given purpose. International regulations and standards including FDA 21 CFR 820.30 and ISO 13485:2016 govern the different phases of Design Controls.

With the use of cloud-based QMS software such as SimplerQMS, you can streamline design control and maintain quality throughout the lifecycle of all your medical devices. If you are interested in streamlining your design control processes using an integrated QMS software solution for medical devices, we recommend booking a demo to talk to our experts and see what SimpleQMS is capable of.