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.

FDA PMA, 510k Submissions and 483 Warning Letter

Bringing a new device to market but need help getting FDA Approval? Been audited by the FDA and issued a Warning Letter? Our experts have worked with multiple companies to receive FDA 510k approvals and clear FDA Warning Letters.

Design Controls and
21 CFR 820

Quality control and quality management systems are essential to ensure FDA and EU compliance. Our team will get your SOPs, Design History Files (DHF) and Device Master Records (DMR) in compliance and working smoothly.

ISO 13485, 14971, 60601, and More

Need help with certifying your company or product to an ISO or other standard? We've worked with dozens of companies to help them get certified and maintain compliance.

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.