Design Control Requirements for Medical Devices

The process of developing a new medical device from scratch to introducing it into market is a complex process, particularly if software is being used by the manufacturer in developing the device as it presents the possibility of subtle errors. Typically, a device has multiple components, some procured from vendors and some developed in-house. After that, the manufacturers assemble all these different components into a finished medical device. The engineering team creating such devices consists of people with particular functional expertise like software development, electronics and materials – everyone needs to collaborate on designing the device. In addition to the design process and its complexities, device testing needs to be adequate to meet the regulatory standards set by Food and Drug Administration (FDA) and other international and domestic standards that are applicable.

Regulation vs. Intent

One of the most common issue that is seen with medical device companies, when it comes to design controls, is the focusing on following the regulation rather than delving into its intentions. The focus is usually on what the words say and not on what the regulation is intending to accomplish.

When it comes to FDA’s design control regulation, which is summarized in Section 820.30 of 21 CFR 820, a literal interpretation is very difficult and is next to impossible. The regulation is very vague and contains limited or less details regarding what manufacturers are required to do in order to meet the requirements – at least mechanically. However, most of the intent of the regulation is common sense or what some might call prudent engineering.

In many regulation, there is a lack of specificity as it needs to be applied to a vast range of medical devices. There are some manufactures who make very simple medical devices and there are others who make much more complicated medical devices. Some manufacturers make devices which never come in contact with a patient’s body and others make create devices that might stay in the patient’s body for the entire lifetime. However, all these manufacturers need to conform to, essentially, the same basic set of design controls.

The FDA regulations provide more of a framework within which manufacturers need to work, instead of providing particular steps for device makers to follow in maintaining and establishing design control procedures. This provides the company with the much required flexibility to create a design control system which not only complies with the regulation, but essentially, helps to ensure that you do what you needs to do as prudent engineers.

To get detailed insight, join this session on Creating a Good Design History File (DHF) for Audit Success by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA. This webinar aims to demystify regulatory requirements for a medical device design control system, and also includes device master record (DMR), design history file (DHF) and device history record (DHR). David will also provide actionable, practical and sustainable guidance on how you can adequately implement design control requirements as quality management system’s subsystem.

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