Expert Regulatory Consulting
Medical Device Regulatory Consulting Services
ISO 13485, EU MDR, FDA QMSR, MDSAP — practical regulatory support from an experienced ISO 13485 Lead Auditor with broad international expertise.
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End-to-end regulatory support — from QMS implementation to international registration.
ISO 13485 Implementation
Full QMS implementation support from gap analysis to certification — including all required procedures, templates, and audit preparation.
EU MDR Compliance
Technical documentation review, clinical evaluation support, PMS system setup, and Notified Body submission preparation under EU MDR 2017/745.
FDA QMSR
Quality Management System Regulation compliance support — gap analysis, procedure development, and FDA inspection readiness.
Audit Preparation
Pre-audit assessment, mock audits, corrective action plans, and on-site support during Notified Body, FDA, or MDSAP audits.
Mock Audits
Realistic mock audits simulating Notified Body or regulatory authority inspections — identify gaps before the real audit does.
QMS Documentation Review
Expert review of your existing procedures, SOPs, and templates — with detailed feedback aligned to current auditor expectations.
International Registration
Market access strategy and registration support for EU, US, Canada (MDSAP), and other international markets.
Internal & Supplier Audits
Conducting internal audits and supplier audits on your behalf — fully documented and aligned with ISO 13485 requirements.
MDSAP
MDSAP audit program preparation and support — covering FDA, Health Canada, ANVISA, TGA, and PMDA requirements simultaneously.
Self-Service Alternative
Prefer to start on your own with audit-ready documentation?
If a full consulting engagement isn't the right fit yet, our compliance kits give you a head start with editable, audit-ready documents you can implement immediately. ISO 13485, MDSAP, or the Combined Bundle — instantly downloadable.
Browse Documentation Kits →Who Is This For?
Startups
Building your QMS from scratch ahead of your first ISO 13485 or EU MDR certification.
SME Manufacturers
Preparing for surveillance audits, recertification, or expanding into new regulatory markets.
Regulatory Consultants
Looking for a specialist partner for specific audit, documentation, or registration projects.
International Companies
Entering EU, US, or Canadian markets and needing regulatory alignment across multiple standards.
Why Work With Us?
15+ years of medical device experience — with broad international expertise across 10+ markets and multiple regulatory frameworks.
ISO 13485 Lead Auditor certified — with direct experience across EU, US, and Canadian regulatory frameworks.
Practical, audit-ready outputs — every deliverable is structured to pass regulatory scrutiny, not just look good on paper.
Multi-standard expertise — ISO 13485, EU MDR, FDA QMSR, MDSAP, and ISO 14971 in a single engagement.
Flexible engagement — project-based, retainer, or hourly support depending on your needs and budget.
Fast turnaround — we understand regulatory timelines are critical and deliver accordingly.
Ready to discuss your project?
Tell us about your QMS challenge and we'll get back to you within 1 business day. No pressure — just a conversation.