Your QMS,
Pairing 40+ Years of Industry Wisdom with AI-Powered Efficiency.
For medical device startups and SMBs, the path to a compliant Quality Management System is fraught with complexity. At qms.coach, we don’t just give you a map—we walk the path with you. We combine decades of in-the-trenches regulatory experience with the speed of modern AI tools to build you an audit-proof QMS that is simple to manage, sustainable, and fosters a true culture of quality.
Why Us?
The Strategist & The Innovator
Our approach is what makes us different. We combine the deep, “in-the-trenches” experience of a 41-year industry veteran with the speed and precision of a next-generation technology expert.
Ian Tovey, our Principal QMS Strategist, provides the irreplaceable wisdom to guide your high-level strategy. Neelank Tiwari, our Technology & Execution Lead, uses a PMP-certified, AI-driven approach to build and implement that strategy with unmatched efficiency. You get the best of both worlds: proven experience and modern results.
QMS Development & Optimization
Audit Preparation & Readiness
Quality Culture Training
AI-Driven QMS Tools
Work smarter, not harder. We implement and train your team on practical, AI-powered workflows to accelerate documentation, analyze complaint data, and streamline CAPA investigations, freeing your team to focus on innovation.
Our Commitment
Our goal is simple: to be the most valuable partner you have on your compliance journey. We are committed to empowering your team, simplifying complexity, and helping you build a quality system you can be proud of. We succeed when you succeed.
Frequently Asked Questions
Traditional consultants often build a system for you, leaving you with a complex binder of procedures your team may not fully understand. Our coaching approach is different. We build the system with you. We focus on empowerment and sustainability, ensuring your team has the skills and confidence to own and manage your QMS long after our engagement ends. We succeed when you no longer need us.
We use AI as a powerful accelerator, not a replacement for human expertise. It helps us streamline the most time-consuming parts of QMS development. For example, AI can draft a compliant Standard Operating Procedure (SOP) in minutes, which we then refine with our industry experience. It can also analyze thousands of complaint data points to identify risk trends that might otherwise be missed. This AI-driven efficiency allows us to deliver a high-quality, compliant system faster and more cost-effectively.
Absolutely. Our service is designed specifically for startups and SMBs. We understand that you need to be lean, agile, and budget-conscious. Unlike traditional, large-scale consulting, our coaching model focuses on building a scalable QMS that meets your immediate compliance needs without unnecessary bureaucracy. Our use of AI translates directly into faster implementation and lower costs, which is critical when every dollar and every day counts.