Darrin Carlson, RAC-Devices, PMP's Linkedin Analytics

Could you handle the pressure of an FDA inspection tomorrow? What if your QMS wasn’t ready, leaving you exposed to costly delays or penalties? For many MedTech companies, audits feel like a disaster waiting to happen. Missed compliance issues can lead to expensive 483s, warning letters, or worse—halted operations. Here’s how I help: With over a decade of experience in internal audits for medical device, pharmaceutical, and combination product manufacturers, I simplify the audit process and help you avoid costly mistakes. My approach combines AI-driven insights with human expertise, so you get precise, actionable solutions tailored to your unique challenges. You’ll know exactly what’s working, what isn’t, and how to fix it—giving you peace of mind before the FDA or a notified body ever steps in. I’ve led dozens of internal audits across key standards and regulations: → ISO 13485 → QSR → EU MDR → MDSAP → ISO 14971 → QMSR If there’s a compliance framework in MedTech, chances are I’ve worked with it. My clients rely on me to prepare them for smooth FDA inspections and notified body audits by addressing issues early—before they become costly problems. Here's what one of my clients said: "Darrin’s meticulous approach and deep expertise identified critical areas for improvement and gave us actionable recommendations. Thanks to his intervention, we now have a clearer understanding of our processes and a robust framework for future growth." Do you need help reducing audit risks and avoiding compliance headaches? → Message me here on LinkedIn and let's chat. → Join 400+ professionals who subscribe to my QA/RA Playbook and get free access to my Fix the Top 6 QMS Issues mini-course! (Link in Featured section.)