Navigating any regulatory environment is intimidating, and it’s easy to overspend on quality initiatives that don’t help with certifications. Provaré can help improve efficiency and margins by building quality and testing processes that make it easy for the FDA inspectors to verify compliance.
You know the medical world needs your products or services. Maybe it’s taking too long to get 510k approvals to ship, or maybe QA issues are squeezing margins. When faced with those problems, it’s easy to over-build (and over-spend) on QA processes that don’t fix the problem. We can improve your speed-to-market and profitability.
We can help you manage through the regulations as well as the regulatory process, and show you how to build more efficient QA processes through clearer and more efficient SOPs. If you make it easy for the regulators to verify compliance, it makes it easier, faster and less expensive to get to market, and ultimately to help patients.
Don’t wait until costs – or worse, warnings – start to mount. Provaré helps clients increase efficiencies and margins by building and documenting clear QA processes. We’ve helped customers like OPTI Medical, PointClear Solutions, Theragenics, Sensus Healthcare and Humana RightSourceRx do just that. Contact us and let us explain how we can help.
Shortly after FDA approval, a new device began generating false negatives and positives. We performed a retro-active requirements analysis and built a test plan that fixed the problem before it became an issue.
OPTI Medical contacted us to determine if Agile development was an option for a company making FDA regulated medical devices. The FDA had not yet released guidance for Agile techniques. We helped them solve problems they were experiencing with heavy validation loads and missed defects. We also addressed how to meet FDA documentation requirements, and implement Agile as well.