When you put a medical device on the market, it must be safe and effective. National and worldwide organizations alike uphold standards of quality that medical device developers must follow. Adherence to these compliance regulations ensures that medical devices do their jobs reliably, without putting users or patients in danger. Understanding the regulations surrounding your medical device is a key part of creating a product that does its job and finds success on the market. Learn more with this guide on regulation and compliance in medical device design.
Stages of Regulatory Control
Compliance regulations review the quality of a product throughout its lifespan. There are three main stages of control that most government regulations consider: pre-market, placing-on-market, and post-market surveillance. Pre-market controls revolve around the development of the device. This includes quality assurance measures to ensure the device complies with all requirements before it goes to the market. Placing-on-market controls address product representation on the market, such as labeling and advertising. These regulations strive to eliminate false advertising and ensure FDA establishment registration. Finally, post-market surveillance controls monitor the device throughout its life on the market to ensure it continues to perform safely and effectively.
Understanding FDA Device Classification
In the United States, the FDA classifies medical devices into one of three classes. These classes determine how much risk your device presents—and thus the amount of regulatory control and scrutiny it must undergo. Class I medical devices make up the majority of the market and present little risk to patients. These include bandages, bedpans, or general wellness apps. Class II devices are medium-risk, non-invasive products such as pregnancy tests, imaging devices, or prosthetics. Class III devices present the highest risk to users. These products are often invasive and life-changing. Examples include pacemakers, ventilators, and implants.
Core Components of Design Controls
Class II and III devices have more of an impact on users, so they fall under the controls for regulation and compliance in medical device design. Medical device developers use the following design controls to inform their entire development process:
- User needs – ensuring your device meets the defined needs of your target users
- Design and development planning – creating a strategy that outlines design controls and how your team will meet them
- Verification and validation – ensuring that you developed the product correctly and that the product fits your intended user needs
- Design transfer – making sure the product continues to work effectively as it moves to the manufacturing phase
- Design changes – applying these and other design controls throughout the lifespan of the device to ensure it continues to meet performance requirements while on the market
Including the above principles in the development process helps guarantee a successful device design. By keeping these compliances and requirements in mind throughout the entire life of your product, you ensure your medical device continues to serve its intended purpose even after its market release.