Applications openDeadline: August 31
Build Your Quality Management System
Build a lean, scalable QMS to comply with ISO 13485, MDSAP, FDA, and MDR requirements, with personalized guidance from quality experts every step of the way
Applications open
Regulatory Strategy Sprint
Confirm your medical device classification and global market entry pathway. Leave with a documented regulatory strategy and intended use statements to support your investor due diligence.
DEADLINE: August 31
Program Outcomes
By the end of this program, you will have a complete quality management system. A well-designed QMS enables your company to:
A compliant Quality Management System tailored to your product classification
Pass regulator audits and inspections
Demonstrate a critical early milestone to investors
Execute business operations more efficiently
Gain customer trust and competitive advantage
Already trusted by Rellia members
“The QMS fits seamlessly within our workflows and is directly personalized to our company and product. Rellia has been excellent to work with - they are true experts in their field.”
Dr Stevie Foglia
Founder & CEO • Neuro-Mod
“The Rellia QMS program was practical and startup-friendly, the process was easy to follow, and the support helped us understand not just what needed to be done, but how to do it properly.”
Ibukun Elebute
Founder & COO • Cellect
“Since joining, we've made real progress on building our QMS which is something that previously felt overwhelming.”
Rooaa Shanshal
Co-Founder • Power of Play
0 / 0
How It Works
Each week, you will receive the following guidance to ensure your success throughout the program.
Classification & Pathway
Determine your product's device classification across FDA, Health Canada, and EU MDR — and map the fastest viable regulatory pathway for each market.
Intended Use Documentation
Draft precise intended use and indications for use statements that align your regulatory, clinical, and commercial strategy from the start.
Global Market Strategy
Build a phased commercialization timeline across key markets, understanding the regulatory dependencies and milestones investors expect to see.
Program Pillars
Compliance Simplified
Complex regulatory requirements are translated into clear, scalable systems appropriate for early-stage companies.
Own Your Own Processes
No two companies operate the same way. We build your QMS around how your team actually works, not with one-size-fits-all templates.
Expert Guidance
Your mentor knows quality inside and out. Together you get it done without adding quality management to your already long list of things to master.
Take It At Your Own Pace
Every startup moves differently. The program flexes to your timeline, capacity, and priorities because we know that your QMS is just one of the hundred things you are juggling right now.
Program Timeline & Details
A structured journey through the key requirements for a successful QMS
Step 1
Step 2
Step 3
Step 4
Monthly subscription
$2000.00
Join the only program designed to help you implement an audit-ready Quality Management System without the headaches.
What's included
- Pause or cancel at any time.
- Weekly consultations
- Instructional content
- Frameworks & templates
Let's Build Your QMS
Still have questions or want to learn more about the program? Reach out at any time to speak with us directly.