Navigating Medical Device Design Control & Risk Management
Helping you navigate integrated design control and risk management, while providing complete visibility into the entire development process for your medical device.
Developing a use specification for your medical device is important—not just for your human factors/usability engineering exercises, but for compliance as well. Because the use specification summarizes characteristics related to the context of device use, it helps narrow the scope of your product and can help you align its intended use to its device type within FDA regulations.
When you’re developing a life science product, risk management is an integral part of your process. It helps you evaluate requirements and design features for hazards and potential harms. But do the resulting risk controls require a separate design review, or can they be reviewed with the design stage they flow back into?
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What’s happening this summer at FDA? Here are a few stories we thought were worth highlighting.
Most life science organizations look to meet regulatory requirements through writing and implementing standard operating procedures (SOPs). However, within SOPs there can be some nebulous areas that can adversely impact the very compliance the procedure was developed to achieve. To overcome this, some organizations implement work instructions: detailed steps to complete tasks identified within the SOP. But can these actually improve compliance? And if so, how?
Rapid prototyping is a design activity that is beneficial throughout product development, not just during early innovation stages. Building low-fidelity models is beneficial for:
As part of an Agile approach to product development, defined user needs help streamline your design and compliance activities for your life science product. But how do you develop those user needs in the first place?
Interactions with FDA are an inevitable part of the lifecycle of your life science products. From premarket activities to postmarket surveillance, interacting with regulatory officials is necessary, and can be valuable to your organization.
If you’re working on a medical device 510(k) submission for the first time, it can feel like a daunting task. On top of your regular design work, you have to prove your device is similar to legally marketed predicate devices that already have been cleared by FDA. While FDA provides plenty of resources for supporting your 510(k) efforts, questions can pop up that aren’t always so straightforward to resolve. Here are some of the most common questions, and answers to help clear things up.