All medical product development is performed in accordance with FDA regulations. We follow an agile development process that is faster than traditional development models because it identifies high risk elements of the design earlier in the development process.
Documentation in accordance with industry standards flows naturally from the development process and is not an after-thought. These design control documents facilitate FDA filings for product clearances including 510(k) and PMA applications.
Risk management is an integral part of the product development process. We use sophisticated FTA and FMEA methodologies to develop risk profiles and mitigations. These analyses are vital to securing FDA clearances.
For a medical device, safety and efficacy are paramount considerations that are subject to verification and validation processes. Verification is ensuring that "the product was built right". Validation is ensuring that "the right product was built". We prepare comprehensive V&V protocols and reports that complement the FDA filings.