Regulatory Compliance

Since the devices we develop have a critical application, we are guided by the most rigorous standards enforced by the US FDA (Food and Drug Administration). Our devices and software are developed with this compliance in mind, and a couple of successful FDA approvals are a testimony to our efforts and knowledge. As a part of FDA approval, we have experience in preparation of regulatory documentation including Premarket Notification, also known as PMN or 510(k). Even if not required, we are always enforcing the right procedures and high development standards, as well as verification and validation tests.

As part of this process, we have a dedicated Quality Assurance team, which constantly tests and monitors the implementation of requirements. Furthermore, our staff has the experience that is needed to satisfy all QA stages, including tracking output according to original requirements, and guiding the product to final acceptance.

Interested in learning more? Contact our team and see how INform can help simplify and cut your product cycle time.

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