Building Your
Quality Management System
FOR EARLY-STAGE HEALTH TECH FOUNDERS READY TO BUILD A STRONG QUALITY FOUNDATION
Whether you’re still refining your prototype or preparing for your first audit, Building Your QMS helps you build a compliant Quality Management System (QMS) from the ground up.
Through weekly SOP templates, personalized mentorship, and hands-on guidance, founders gain the knowledge, structure, and confidence to meet industry standards bridging the gap between innovation and compliance.
About The Program
Welcome, healthtech founders, to Building Your QMS!
As founders, you’re not just building innovative solutions; you’re also laying the foundation for long-term growth, patient safety, and business success. A strong Quality Management System (QMS) ensures your product meets regulatory requirements, builds credibility with investors and partners, and most importantly, safeguards the patients and providers you serve.
We know how expensive and challenging regulatory consulting can be for founders. That’s why we’ve created a program designed with you in mind: founder-friendly, practical, step-by-step, and catered towards the unique challenges of your health tech startups.
Over the coming weeks, you’ll learn how to build clear and effective Standard Operating Procedures (SOPs), gain tools and templates to streamline your processes, and start building your QMS as you prepare for those submissions.
By the end of this course, you’ll not only see why a QMS matters, but you’ll also walk away with the procedures put in place to crush those regulatory barriers!
I’m excited to support you on this journey. Let’s get started!
Warmly,
Megan Kane
How it Works
Each week, you will receive the following materials to ensure your success throughout the program…
SOP Template
This template outlines the framework you’ll follow to document, organize, and implement your Quality Management System step by step.
Instructional Video
This instructional video walks you through how to complete the template step-by-step and apply it to your Quality Management System.
1-on-1 Mentorship Meeting
Get dedicated time with a QMS mentor who will help you troubleshoot challenges, refine your SOPs, and ask any questions you may have.
Program Pillars
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Compliance Simplified
We understand how overwhelming quality assurance and regulatory compliance can be for founders who are juggling many things at once. We synthesize complex topics into clear, actionable steps to help you understand why each process matters and how to effectively implement it.
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Build While You Learn
Each week, you will be provided with educational material and expert-designed templates to construct your Standard Operating Procedures (SOPs) that form the foundation of your QMS. By the end, you’ll have a functioning system that’s ready for audits and investor scrutiny.
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Founder-Centered Mentorship
You’ll receive personalized, one-on-one mentorship from our regulatory and quality expert. Our goal is to meet you where you are and work with you to customize your path forward.
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Take It At Your Own Pace
We will prescribe a timeline to help keep you on track. However, we understand that every startup is different and moves at a different pace. We are flexible to adjust timelines according to your schedule.
Program Timeline & Details
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Week 1: Document and Record Control, Training and Qualification
Week 2: Work Environment, Information Security
Week 3: Product Development
Week 4: Risk Management
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Week 5: Supplier Management
Week 6: Purchasing, Incoming Quality Control, Process Software Validation
Week 7: Production, Operations
Week 8: Validation, Change Management
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Week 9: Marketing, Sales, Installation, and Support
Week 10: Shipping, Labeling
Week 11: Complaint Management
Week 12: Nonconformities and CAPAs
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Week 13: Audits
Week 14: Regulatory, Legal, Adverse Events, and Recalls
Week 15: Analysis, Improvements, and Management Responsibility
Week 16: Quality Manual