Developing Design Controls

by | Aug 12, 2021 | Design Controls, FDA, ISO, Medical Devices, Product Development, QMS

Design controls are a necessary and critical element in the QMS and overall development of any medical device or product. Design controls establish a planned set of procedures and steps for the design and development of a device. Design controls not only allow for an easier design and development cycle for a product but also connect many key QMS subsystems to each other. As well as connecting QMS subsystems efficiently, design controls will also impact and control the product’s pre-market design and development as well as any post-market changes.

It is of the utmost importance that medical devices and products are inherently designed with safety. Therefore, the essential outcome of properly implemented design controls is the design and development of a safe product. Design controls are an FDA term that is defined in 21 CFR 820 but is also heavily referenced in ISO 13485. Design controls are a means of efficiently documenting every step of the development process to control the product. Without design controls, collaboration among research, engineering, quality, and operations might be very difficult, as respective roles and responsibilities are all defined in a design controls QMS sub-system. Design controls can be utilized throughout the entire design and development of a product and should act as a sort of workflow guidance for how and when certain stages in the development of a device should be completed. Design controls include, but are not limited to, design and development planning, design inputs, design outputs, design review, design verification, design validation, design transfer, design changes, and a design history file. Although these are typically used as FDA terminology, these procedures and aspects of the design controls are easily translated to required procedures for ISO 13485.

Design controls are inherently meant to ensure a developed device or product is safe, meets the defined requirements, and meets a user’s needs and intended uses. The traceability of all related aspects of design controls is also incredibly important for all who are involved. Therefore, a Design History File (DHF) is meant to organize and store all the design controls in an easily accessible manner. A DHF should maintain and reveal the linkages and relationships among all the design controls. A DHF makes it easier for any member of product development to reference any aspect of the design as well as the history of that input or output.

Design controls should be a systematic method for documenting and demonstrating the process of developing a medical device. Medical device development should follow a structured approach, that can be traced at any stage of the design. For help or assistance with design controls, or anything medical device-related, contact EMMA International by phone at (248) 987-4497 or by email at Our experienced team has developed and implemented fully functional QMS’s, including design controls, and can help you meet your product or devices goals.


Kareem Arafat

Kareem Arafat

Quality Engineer- Mr. Arafat has experience in combination products, pharmaceuticals, and FDA compliance for many life science industries. He has experience with many different elements of quality and regulatory compliance. Mr. Arafat holds a Bachelor of Science in Materials Science & Engineering from Michigan State University.

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