Medical Device Quality Engineering Consulting and Contracting Tailored to Your Needs
Quality Problems Solved.
Getting Medical Devices to market and keeping clear of audit findings is tough. We help you get your device to market, maintain its quality, and clear audit findings.
Exceptional Solutions in Tough Situations
No one wants to hear that bad news – you’ve been issued a 483 Warning Letter or the FDA is requesting additional information for approval of your 510k. You need to solve problems in your quality system or product documentation fast.
This is where Iron Med excels. We learn and adapt rapidly to your quality system and your needs, generating useful work in just days, compared to weeks for most other consulting firms. Our team specializes in stepping into high-pressure situations and delivering outstanding, on-schedule results.
The Expertise You Need, When You Need It
It happens to every business – a new need arises, but your project team doesn’t have the bandwidth or perhaps expertise to easily solve the problem at hand. Therefore, you need support.
Iron Med Consulting is there for you when you need it. We specialize in developing documentation specifically to meet the required regulations and standards within existing quality system frameworks. We’ve worked with dozens of companies to help them get their devices to market or to keep them on the market.
Therefore, don’t hesitate to reach out! Speak today with one of our experts and find the support you need.