• Provision Consulting Group

FDA Regulatory Design Control Requirements for Medical Device Startups

May 23 2022


The U.S. Food and Drug Administration (FDA) recognizes these risks and strictly regulates design control requirements to produce safe and effective medical device products for widespread use. Failure to comply with these and other regulations can be a major impediment to obtaining prompt FDA approval.


In particular, improper design of medical devices is the biggest cause of product recalls. We've outlined three FDA requirements for product design so that your product may receive quick FDA clearance and be released on time.



Design Planning


Proper planning for your product design is a major prerequisite for an effective design system. The design planning process begins with a review of the design control goals and objectives. For best results, first establish all design control procedures, practices, and systems.


Once your team sets the design control goals and objectives, considering how to manage and enforce design controls is the next step in producing the most effective, safe and optimized regulatory of your product.


During this stage, the quality team properly documents all control activities, and a document management system (DMS) makes the design control planning procedure much easier. This system identifies the teams influencing the medical device design and It is important.


A document management system (DMS) makes the design control planning phase much easier.



Design Inputs


Design input is including performance data, regulatory requirements, labeling, and more. 21 CFR 820.30(f) and ISO 13485 to maintain comprehensive documentation related to all design control and quality processes.


ISO 13485:2016 7.3 covers much of the same design input requirements.



Design Management


21 CFR 820.30 requires medical device manufacturers to enable risk mitigation.


eQMS can help you streamline the entire process and it helps to identify and control important information related to the design process.


eQMS is designed to help teams develop a proactive approach to quality management and compliance. In addition, quality teams can easily generate documentation and reporting with this system. It helps save your team's time since most will want to see detailed reporting related to your design controls and inputs.


Medical device startups are encouraged to utilize eQMS to easily set up quality procedures, as well as invest in and maintain a quality system, and almost guaranteed FDA approval.


Most advanced product is focused intensively on the quality of the design process. For this, many teams invest in eQMS to proactively identify the areas of risk or non-conformity for a device.




If you approach the review time with FDA,

consider and prepare these requirements for your device design properly.


We will streamline the regulatory processes so that our clients can utilize

their time and money most efficiently.


Experience the best FDA approval directions and solutions!



If you have questions about FDA regulation of medical devices

or importing of medical devices to the United States,

please CONTACT US.


Office 1-909-493-3276

Email ask@provisionfda.com