Once you've come up with an idea for a medical device, the next step is to create a medical device design that is safe and effective for the end user. Medical device companies must also establish design controls - a set of policies and procedures for documenting the steps in the design process and ensuring that the medical device you design fulfills its intended purpose and is both safe and effective for the end user.
The key to an effective medical device design process is remembering that the device itself is not the only intended output of the medical device design process. You are also expected to produce a user manual for the device, clearly documented specifications that explain how the device is constructed and how it works, a detailed risk analysis that quantifies the risks associated with your device, technical files, and the results of any testing or studies that you conduct (product validation, bio-compatibility, clinical risk assessment, etc.).
User needs are the first thing that you need to establish and document if you're about to start designing a medical device.
If you're short on time, we've outlined the basic steps to an effective design control process below:
For companies who begin medical device design without paying appropriate attention to the design controls process and other medical device regulations, establishing proper documentation and getting their device to market quickly becomes and impossible uphill battle. Greenlight Guru's eQMS is the quality management tool that medical device companies need to help ensure that design controls are established, followed and stored in compliance with FDA and ISO regulations.
Medical device companies that wish to sell their products in the United States will have their quality systems audited by the FDA. Greenlight Guru makes it easy to store, access and share all of your design control documentation, proving your compliance with local regulations and helping you get to market even faster.