Done with Template-Dumping consultants?

No more Excel chaos, half-baked SOPs, or one-size-fits-none templates.

Scalable QMS for Fast-Moving innovators

Whether you’re building a traditional medical device or an AI/ML algorithm, setting up a Quality Management System (QMS) doesn’t have to be overwhelming or overly rigid. Your QMS should reflect your product, your people, and your stage of growth.

At LucidMind consulting, We design clean, smart and scalable QMS that are actually usable. We closely work with each team of your organization to understand the gaps and build processes that are tailored to your unique needs and compliant with the relevant QS regulations: ISO 13485, FDA QSR (21 CFR Part 820), and EU MDR

The Problem: Quality Chaos

Excel chaos everywhere
SOPs that nobody follows
Audit panic mode
Template dumping without strategy

Our Solution: Strategic Quality

Clean, scalable QMS architecture
Processes built for your stage
Audit-ready from day one
Strategic quality planning

Global Compliance

Quality systems that are designed to meet the most stringent international standards.

ISO 13485

International quality management standard for medical devices

FDA QSR

US Quality System Regulation compliance

EU MDR

European Medical Device Regulation requirements

From Zero to Audit-Ready

Whether you’re a startup just stepping into regulatory waters or a mid-size company, scaling up with a growing product line, we help you go from zero to audit-ready minus the jargon and stress!

Startups

Building from scratch

Get your quality foundation right from the beginning. No over-engineering, just what you need to grow.

Essential QMS framework
Scalable processes
Regulatory readiness
Cost-effective approach

Scaling Mid-size

Growing pains solutions

Transform your existing systems into a professional QMS that scales with your ambitions.

System optimization
Process standardization
Team training
Efficiency improvements

Preparing for Certification

Audit-ready excellence

Final preparations for regulatory inspections and certifications. Leave nothing to chance.

Audit preparation
Gap analysis
Documentation review
Mock inspections

Roadmap to a compliant, scalable QMS

1

Gap assessment

Identifying and analyzing gaps

Week 1-2
2

Foundation

Core QMS structure

Week 3-6
3

Implementation

Process deployment

Week 7-12
4

Audit-Ready

Validation & training

Week 13-16
5

Internal Audit

Evaluating QMS effectiveness and compliance through a structured internal audit.

Week 17

Ready to Build Quality That Scales?

Let's discuss how we can transform your quality systems and prepare you for success.