QMS Document Programs
Turnkey and custom Quality Management System documentation — SOPs, work instructions, forms, and full-procedure suites aligned to FDA QMSR, ISO 13485, and MDSAP requirements.
Medical Device Consulting
Precision.
Precision.
Purpose.
Compliance.
Expert quality and regulatory guidance for medical device organizations — from emerging startups navigating their first submission to global enterprises managing multi-site QMS programs.
FDA
510(k), De Novo & PMA Pathway Guidance
ISO
13485 · MDSAP · 14971 Compliant Programs
EU
MDR · IVDR · EUDAMED Registration Support
QMS
Full Build-Out to Single-Document Programs
About Kairos QRS
The Right Guidance, At the Right Time.
Kairos — the Greek word for the appointed, perfect moment — is more than a name. It is our commitment: to bring the precise expertise you need, exactly when you need it most.
Kairos QRS is a boutique medical device consulting practice offering deep quality and regulatory expertise to organizations at every stage — from early-stage startups building their first QMS to multi-site enterprises navigating complex global submissions.
We believe great regulatory strategy is not reactive — it is intentional, purposeful, and precisely timed.
"We don't just identify compliance gaps — we build the roadmaps, documents, and systems to close them permanently."
Precision
Every recommendation grounded in current regulation and practical industry experience.
Integrity
Honest, unbiased guidance — never oversold, always aligned to your actual needs.
Scalability
Programs designed to grow with you — from single-product startups to global portfolios.
Partnership
We embed as an extension of your team — not just a vendor, but a trusted advisor.
What We Do
Core Service Offerings
Comprehensive quality and regulatory solutions tailored to your organization's stage, size, and market ambitions.
Validation Guidance & Review
Protocol development, review, and execution support for IQ/OQ/PQ, cleaning validation, software validation, and process validation — with regulatory defensibility built in.
QMS Build-Out & Implementation
Full-scale QMS design and implementation for startups and growing companies — from gap assessment and framework selection through document creation, training, and go-live.
Regulatory Submissions & Strategy
FDA 510(k), De Novo, and technical file strategy — predicate analysis, regulatory pathway assessment, submission writing support, and Health Canada/EU MDR guidance.
Audit Readiness & Mock Audits
Pre-audit preparation, CAPA strategy, mock FDA and ISO 13485 audits, and post-audit response drafting — so your team walks into every audit with confidence.
Post-Market Surveillance & MDR
PMS plan development, PSUR authoring, MDR/vigilance procedure creation, complaint trending, and proactive field safety signal monitoring aligned to EU MDR and FDA requirements.
07
Trade Compliance Guidance
Navigating international trade regulations for medical devices — from HTS classification and import/export controls to FDA import alerts, country-of-origin requirements, and cross-border distributor compliance frameworks.
Who We Serve
From Startups to Enterprise
Startups
First QMS, first submission, first audit — we build the foundation that scales with you.
Growing Companies
Scaling operations, new product lines, or entering global markets — we keep compliance ahead of growth.
Multi-Site Organizations
Harmonizing QMS across global sites, legal entity changes, MDSAP and multi-jurisdiction registration management.
Enterprise Teams
Surge capacity, specialized expertise, regulatory intelligence, and independent quality oversight when internal teams need reinforcement.
Document Programs
Ready-to-Implement QMS Document Suites
Our signature document program offering delivers regulation-ready procedure suites — fully customizable, audit-defensible, and structured for real-world use. Not generic templates. Purpose-built programs.
Request a Program Quote01
Post-Market Surveillance Suite
PMS Plan, PSUR template, Vigilance WI, Trend Analysis procedure, and MDR reporting forms — EU MDR & FDA aligned.
02
CAPA & Complaint Management Program
End-to-end CAPA procedure, complaint handling SOP, MDR determination wizard, and effectiveness verification tools.
03
Supplier Qualification & Control Program
Supplier qualification packet, approved supplier list, audit criteria matrix, and re-qualification triggers — MDSAP-ready.
04
Internal Audit Program
Global internal audit schedule, checklist library, findings log, and corrective action follow-through templates — multi-site capable.
05
Custom QMS Build
Full procedure framework built to your scope, standard, and eQMS platform — from first draft through controlled release.
Trade Compliance
Global Trade. Regulatory Precision.
Medical devices crossing international borders face a layered compliance landscape that goes beyond product registration. Tariff classification, import entry requirements, FDA detention and import alert status, export licensing, and distributor compliance obligations can delay shipments, trigger penalties, or derail market access.
Kairos QRS bridges the gap between regulatory affairs and global trade compliance — providing guidance that keeps your supply chain moving and your international distribution defensible.
HTS Classification
Accurate Harmonized Tariff Schedule classification for medical devices — reducing duty liability and preventing import holds.
Import/Export Controls
EAR, ITAR applicability reviews, export licensing guidance, and restricted party screening program support.
FDA Import Alerts
Import alert strategy, detention response, and supplier remediation plans to restore compliant import status.
Distributor Compliance
International distributor quality agreements, compliance frameworks, and market-specific regulatory obligation mapping.
"From first import to multi-country distribution — we ensure your global supply chain is as compliant as your device."
Our Approach
How We Work With You
Every engagement begins with listening. We adapt our process to your organization's current state, goals, and timeline — not the other way around.
1
Discovery
In-depth assessment of your current regulatory and quality state, gaps, and strategic objectives.
2
Strategy
A prioritized roadmap with clear deliverables, timelines, and regulatory rationale — built for your resources.
3
Execution
Hands-on delivery of documents, submissions, guidance, and reviews — in partnership with your team.
4
Sustain
Ongoing support, program maintenance, and regulatory intelligence to keep your compliance ahead of change.
Regulatory Expertise
Standards & Frameworks We Work In
FDA QMSR
21 CFR Part 820
ISO 13485
2016 · QMS
EU MDR
2017/745
MDSAP
Multi-jurisdictional
ISO 14971
Risk Management
510(k) / PMA
FDA Submissions
Health Canada
MDEL · MDL · SN48
UKCA / MHRA
UK Registration
IEC 62304
Software Lifecycle
EUDAMED
UDI · Registration
EU IVDR
2017/746
Swissmedic
CH MedDO
HTS / HTSUS
Tariff Classification
EAR / ITAR
Export Controls
CBP / FDA
Import Compliance
Get Started
Ready for precision regulatory guidance?
Whether you need a single document reviewed, a complete QMS built, or an expert in your corner for an upcoming submission or audit — let's talk.
Email
[email protected]
Location
South Florida & Remote / Nationwide
Focus
Medical Device Quality & Regulatory Affairs