Book 30-min Call

Book 30-min Call

QMS.Coach LLC Coaching Services

Sign in Subscribe

Neel@QMS.Coach

Building Your First QMSR-Compliant QMS from Scratch

If you're a medical device startup building your first quality management system, you have an advantage: you can build it right from the start. You're not transitioning from QSR to QMSR—you're starting fresh with QMSR requirements as your foundation.

What to Expect in Your First QMSR Inspection

FDA inspections after February 2, 2026 will look different. Inspectors will reference ISO 13485 clause numbers instead of QSR sections. They'll request records that were previously exempt—management review minutes, internal audit reports, supplier audit documentation.

Risk Management Under QMSR: Practical Implementation Guide

Risk management is the philosophical centerpiece of ISO 13485—and by extension, QMSR.

Beyond the CAPA: The Future of QMS Coaching is Predictive

As your QMS Coach, I spend a lot of time helping you build robust, audit-proof CAPA systems. We focus on getting the root cause right, verifying the fix, and proving effectiveness. This is the bedrock of compliance. But what if we could prevent the failure from ever happening? For too

The QMS Coach Playbook: 5 Steps to an Audit-Proof CAPA System

As a QMS Coach, I've seen hundreds of quality systems. The single process that tells me the most about a company's health? Its CAPA (Corrective and Preventive Action) system. A CAPA system isn't just a regulatory "to-do list" (per 21 CFR 820.

Ready to be QMSR-compliant before Feb 2, 2026?

Book a free 30-minute call — no pitch, just your custom gap plan.

Book 30-min Call

html

Yes – Book My Free 30-Minute Call Now