Expert Design Control Services by Innovenn

What are Design Controls?

Design Controls are a set of product development processes and procedures that medical device manufacturers must follow to ensure that their products are safe and effective for their intended use. This process is utilized to confirm the medical device meets the user needs, requirements and intended uses. Controls for the design and development processes are a requirement of regulatory agencies worldwide. While the FDA enforces Design Control requirements through 21 CFR part 820 in the United States, ISO 13485 is an international standard for quality management systems. Adherence to ISO 13485 shows a global consistency in regulations for basic Design Control elements for medical devices in all countries. Design Controls provide a framework for developing outputs and records that are maintained in the design history file of a medical device throughout its life cycle.

Design Controls Process

The Design Controls process comprises several phases, including:


Design and Development Planning: Establish plans that describe the design and development activities. This includes how the project team members will communicate with each other, their roles and responsibilities, timelines, and sequence of activities.


User Needs: Identify the needs of the end-user and the intended use of the device. The intended use what the device will be used for.


Design Input: Define the design requirements for the device, such as its performance specifications and acceptance criteria.


Design Output: Develop the device’s design, including its specifications, drawings, and other documentation.


Design Verification: Test and evaluate the device to ensure that it meets the design requirements and specifications, meaning that the design outputs meet the design inputs.


Design Validation: Test the device in its intended environment and use conditions to ensure that it is safe and effective for its intended use. Testing also ensures that the medical device meets the user requirements.


Design Transfer: Transfer the design of the device from the development stage to the manufacturing stage.


Design Changes: Manage and document any changes made to the device’s design throughout its life cycle.


Design Review: Review the design and development phases to evaluate if the design is ready to move to the next phase of development. A review is typically planned at the end of each phase, but the number of reviews varies based on the complexity of the device’s design. The design review frequency is defined up front in the Design and Development planning.

What is a Design History File and Why is it Important?

A Design History File (DHF) is a collection of documents and records that provide a complete history of the device’s design and development. The DHF is an important tool for demonstrating compliance with the FDA’s Design Control requirements and should include all documentation related to the device’s design, testing, and production.

Do I Need to Use Design Controls for My Medical Device?

Design Controls are required for all medical devices, regardless of their classification (Class I, II, III). However, the level of documentation required will vary depending on the device’s classification and the level of risk to the user or patient. Class III devices, which are considered high-risk, will require the most extensive documentation and testing.

Comparison of Design Control Requirements for Class I, II, and III Medical Devices

Class I Class II Class III
Minimal documentation and testing requirements Moderate documentation and testing requirements Extensive documentation and testing requirements
Examples include simple devices such as bandages and elastic bandages Examples include devices such as powered wheelchairs and surgical drapes Examples include devices such as implantable pacemakers and heart valves
Generally considered low-risk Generally considered moderate-risk Generally considered high-risk

Why Choose Innovenn?

At Innovenn, our team of experts has the experience and knowledge to guide you through the complex Design Control process. With over 250 years of collective experience, our team has the skills and resources to help you develop a medical device that is safe and effective for its intended use. We understand the importance of getting your device to market as quickly and efficiently as possible and will work closely with you to support regulatory submissions. By choosing the Innovenn team to support you as you develop your device, you’re choosing experts to support you in establishing Design Controls and curating key documentation for your Design History File.


Do I need to have a Design History File for my Class I medical device?

Yes, a Design History File is required for all medical devices regardless of their classification.


What is the difference between Design Verification and Design Validation?

Design Verification is the process of testing and evaluating the device to ensure that it meets the design requirements and specifications. Design Validation is the process of testing the device in its intended environment and use conditions to ensure that it is safe and effective and meets the intended use.

Can I outsource the Design Control process?

Yes, manufacturers can choose to outsource some or all of the Design Control process to a third-party consultant or service provider. It is important to ensure that the provider is experienced and knowledgeable in the Design Control process and FDA regulations. A detailed Design and Development Plan will need to be established describing roles and responsibilities throughout the development of the product.

How often should I review and update my Design History File?

The frequency of review and update of Design History File should be based on the product/project specific plans outlined by the manufacturer dictated by the Quality Management System. It is important to ensure that the DHF is a living process, is up-to-date, and includes all relevant information about the design and development of the device throughout its life cycle.