Your Strategic Partner
Bridging FDA Standards with Global Regulatory Excellence
Clearpath MedTech Compliance is a regulatory and quality consultancy for medical device and in vitro diagnostic (IVD) manufacturers. We support you at every stage, from QMS setup and streamlining to remediation, FDA 483 and warning letter responses, supplier assessments, mock and internal audits, technical file preparation and review, and team training. Additionally, we serve as a trusted US Agent and US Registration Agent for non-US medical device and IVD manufacturers, supporting their US market entry and ongoing compliance. Our expertise covers US FDA 21 CFR Part 820, EU MDR and IVDR, UK MDR/UKCA, ISO 13485, ISO 9001, MDSAP, and country-specific requirements worldwide, giving you a clear path to compliance and market access.
At Clearpath MedTech Compliance, patient safety is at the heart of everything we do. Every medical device and IVD reaches a real person, and behind every requirement in a quality system is a patient who depends on that product to perform safely and reliably. That belief shapes how we work with every client.
Our mission is to make compliance clear, practical, and achievable. We see regulations not as a burden but as a framework that protects both patients and your business. A well-designed QMS does more than satisfy auditors: it safeguards your company against costly recalls, regulatory findings, and reputational damage, while building a strong foundation for sustainable growth.
What sets us apart is our hands-on, partnership-driven approach. We don't just hand over documents or point out gaps; we work alongside your team to build quality systems that are right-sized, efficient, and built to last. We design every process with the end user in mind, removing the bottlenecks commonly found in QMS, such as slow document approvals, overcomplicated procedures, CAPA backlogs, and paperwork that adds effort without adding value. The result is a quality system your team can actually work with, one that supports productivity instead of slowing it down. Whether you're a startup establishing your first QMS, an established manufacturer responding to an FDA 483, or a company preparing for EU MDR/IVDR certification or MDSAP, we deliver practical solutions tailored to your products, your people, and your goals.
Our expertise spans FDA 21 CFR Part 820, EU MDR and IVDR, UK regulations, ISO 13485, ISO 9001, MDSAP, and country-specific requirements worldwide. Our goal is simple: to give you a clear path to compliance, confidence in every audit, and the freedom to focus on what matters most, which is delivering safe, innovative products to the patients who need them.
Path to Compliance
We guide medical device and IVD manufacturers through every compliance phase, from QMS design and remediation to FDA 483 responses, certification, and audits. We also act as a US Registration Agent for non-US companies seeking market access, prioritizing patient safety and business protection.
QMS & Compliance Ops
We design and update QMS frameworks to satisfy ISO 13485, FDA QMSR (21 CFR 820), and MDR/IVDR. Our systems ensure high-level compliance while remaining lean and efficient for daily operations.
Audit & Inspections
Master audit readiness with internal audits, mock inspections, and supplier audits. We find gaps early, ensuring you are fully prepared for FDA, ISO 13485, MDSAP, and MDR/IVDR scrutiny.
Enforcement Response
Expertly manage FDA 483 and Warning Letter responses. We build practical remediation plans that stabilize your QMS and align with FDA QMSR, 21 CFR 820, and ISO 13485 for long-term confidence.
International Markets
Master EU MDR, IVDR, UKCA, and MDSAP requirements. We provide expert technical file reviews, documentation prep, and ISO 13485/9001 support to secure and sustain your global market access.
Proven Compliance
100%
483 Resolution
Zero
Audit Failures
50+
Part 820 QMS Projects
Broad Network of Regulatory & Quality Experts
Regulatory & Quality Experts
Expertise
IVDs
Specialized support for IVD companies navigating ISO 13485 and IVDR, ensuring diagnostic performance and strict compliance throughout the entire product lifecycle.
Med Devices
Comprehensive 21 CFR Part 820 guidance for all device classes. We manage FDA 510(k) paths and PMA requirements with a focus on quality and regulatory safety.
Startups
Building lean ISO 13485 compliant systems for innovators, ensuring early-stage ventures are prepared for FDA inspections and successful commercialization transitions.
Process
Your roadmap to global compliance
01
FDA Gap Review
Assessing your current state against the required standards and regulations, typically ISO 13485, FDA 21 CFR 820 (QMSR), and any other applicable frameworks.
02
QMS Design
Architecting or redesigning a quality management system that aligns with your defined requirements—typically ISO 13485 and FDA 21 CFR 820 (QMSR), with MDR, IVDR, and other regulations incorporated as needed.
03
Execution
Implementing targeted updates and remediation actions so new processes, documentation, and controls work smoothly in day-to-day operations.
04
Certification
Achieving audit success, regulatory clearance, and certification or certification reinstatement with confidence.
Proven Success
Partner with Clearpath to transform FDA 21 CFR 820 (QMSR), ISO 13485, MDSAP, and ISO 9001 requirements into strategic assets. Ensure patient safety and global access across EU MDR, IVDR, and other country-specific markets. Book your expert consultation today.
Clearpath was instrumental in resolving our FDA 483. Their deep understanding of 21 CFR Part 820 requirements allowed us to overhaul our QMS and pass the follow-up inspection without issue.
Quality VP
Facing a Warning Letter was daunting, but Clearpath provided the ISO 13485 expertise and remediation strategy we needed to satisfy the FDA and maintain our high standards.
COO, Med Device
They are the gold standard for Part 820 compliance. Their team didn't just give us a manual; they built a culture of quality that makes every internal and external audit a success.
Head of Quality
Clear Path to Compliance
Get your FDA QMSR (21 CFR 820) gap assessment
Get your ISO 9001 gap assessment
Get a tailored gap assessment for other applicable standards and regulations