It should come as no surprise that faulty and fraudulent medical devices have harmed many unsuspecting people. This is why the U.S. Food and Drug Administration (FDA) maintains stringent regulations to help ensure health care products are safe and effective. Among these requirements is a quality system regulation that directs manufacturers to develop procedures and controls for the medical device design process. Failure to establish these controls can impede efforts to obtain FDA approval. This documented and iterative approach can also elevate a company’s efficiency and productivity, which is crucial to streamlining product development.

Documenting the Design Process

Medical device design controls are used to create a design history file (DHF) of a product’s mechanical, electrical, or software features. This comprehensive documentation strategy can confirm two things: 1) the design output meets the design input requirements, and 2) the device concept fulfills its intended use by meeting applicable consumer, technical, and regulatory conditions. Ideating and outlining these critical details makes it easier to provide accurate, readily available design data for internal and external review. Design controls also inform the practices used later in the development and manufacturing phases.

Document control software (also known as a document management system) can help to safeguard and manage the medical device design process. Document control is essential to an efficient quality management system because it supports collaboration and communication among project team members. Furthermore, it demonstrates that the development approach and final product comply with FDA regulations and other mandates.

Managing and Forming Design Input

Perhaps the most important aspect of medical device design control is building processes that dictate how a product comes together. This design input determines both form and function, which are vital to achieving a safe and effective concept. Properly defining physical and performance requirements can reduce the chances for rework/redesign, which avoids extra costs and speeds time to market.

Establishing Design Validation Procedures

Before design concepts are approved for manufacturing, they must first undergo validation. This step is necessary to prove that the development pathway will consistently meet FDA design control specifications as well as technical standards such as ISO 13485. ISO, the world’s largest developer of voluntary international standards, created ISO 13485 to help medical device organizations manage quality throughout a product’s entire life cycle.


There are two types of validation in the medical device industry. Both methods rely on objective evidence to support design specifications (aka “outputs”) and may be conducted simultaneously in some instances.

  • Process validation shows that a specific process can repeatedly achieve predetermined specifications for a medical device.
  • Design validation demonstrates that a medical device’s predetermined specifications align with user needs and intended use.


As with design input, companies should form strategies for validation early in the medical device design process. Keep in mind that design input should inform the evaluation criteria. But what happens if process validation efforts expose any deficiencies in the design validation, or vice versa? In such cases, the development methodology should be reviewed and corrected until the desired results are attained.

Testing medical devices in simulations that approximate their real-world use should be part of the validation process. Products used in testing must share the same manufacturing methods as those slated for the marketplace. Each medical device concept is unique, so testing alone may not reveal every possible design or production flaw. It’s important to supplement additional validation methods to ensure a safe, effective product. 

Design controls for the medical device industry help maintain a safe, streamlined development process. They protect end-users from harmful products and improve business practices by making medical device companies more transparent and efficient. Encouraging developers to thoroughly test and prove their concepts also builds consumer confidence.

Are you looking to create medical device design controls for your product? The skilled experts at Pathway Medtech can help! Contact us today to schedule a consultation.