MedTech Regulatory Consulting
Your Partner for EU and USA MedTech Compliance
Mastering the EU MDR & IVDR Landscape
We provide clarity on the complex requirements of the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). We help determine device classification, interpret GSPRs, and identify the optimal conformity assessment route.
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Device Classification Strategy
Accurate interpretation of classification rules (Annex VIII). -
Navigating GSPRs
Ensuring your device meets General Safety & Performance Requirements. -
Conformity Assessment Route Selection
Identifying the most efficient path based on device class. -
Understanding Economic Operator Roles
Clarifying obligations for Manufacturers, ARs, Importers.
Navigating US FDA Title 21 CFR Regulations
We provide expert guidance to help you navigate the U.S. Food and Drug Administration (FDA) regulations for medical devices, primarily detailed in Title 21 of the Code of Federal Regulations (CFR). Our services cover device classification, selection of appropriate premarket pathways (e.g., 510(k), PMA, De Novo), and adherence to the Quality System Regulation (QSR) as per 21 CFR Part 820.
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Device Classification & Pathways
Determining your device's FDA class (I, II, III) and identifying the most suitable regulatory pathway (510(k), De Novo, PMA, Exemptions). -
Quality System Regulation (QSR)
Assisting in establishing and maintaining a QMS compliant with 21 CFR Part 820, including Design Controls, CAPA, and P&PC. -
Premarket Submissions & Notifications
Support in preparing and structuring key FDA submissions such as 510(k) Premarket Notifications, Investigational Device Exemptions (IDEs), and Premarket Approvals (PMAs). -
Establishment Registration & Device Listing
Guidance on FDA annual registration for manufacturers and initial importers, and the device listing process.
Global QMS: EU MDR/IVDR & US FDA QSMR Ready
We specialize in developing, implementing, and remediating robust Quality Management Systems (QMS) engineered for seamless compliance in both the European (EU MDR/IVDR, aligned with ISO 13485:2016) and United States (FDA QSMR - Title 21 CFR Part 820) markets. Our core strength and experience lie in effectively harmonizing ISO 13485 with US FDA QSMR requirements, ensuring a streamlined and efficient approach to global regulatory demands, including integrated risk management (ISO 14971).
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Unified QMS Strategy & Implementation
Developing tailored strategies for integrated quality systems that meet both EU and US regulatory requirements efficiently. -
ISO 13485 & FDA QSMR Harmonization Expertise
Leveraging deep experience to align and integrate ISO 13485 principles with the FDA's Quality System Management Regulation (QSMR). -
Comprehensive Risk Management (ISO 14971)
Embedding global best-practice risk management throughout your product lifecycle, satisfying diverse regulatory expectations. -
Dual-Market Audit Readiness & Support
Preparing your harmonized QMS for successful Notified Body (EU) and FDA (US) inspections, plus internal and supplier audits.
US FDA Documentation: DHF, Labeling & CSV Expertise
We offer specialized expertise in preparing and managing comprehensive documentation essential for US FDA compliance. Our services ensure your Design History File (DHF), manufacturing records (DMR/DHR), US-specific labeling, and Computer System Validation (CSV) packages meet stringent FDA requirements.
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Design History File (DHF) Compilation
Meticulous assembly of your DHF to demonstrate design and development in accordance with 21 CFR 820.30, ensuring full traceability. -
Device Master & History Records (DMR/DHR)
Guidance on establishing and maintaining compliant Device Master Records (21 CFR 820.181) and Device History Records (21 CFR 820.184). -
FDA Labeling & UDI Compliance
Ensuring device labeling, including Instructions for Use (IFU) and packaging, fully adheres to FDA regulations (21 CFR Part 801) and UDI system requirements. -
Computer System Validation (CSV)
Expert validation of software used in your quality system or production processes, aligning with FDA guidance and, where applicable, 21 CFR Part 11.
Preparing Comprehensive Technical Documentation
We guide you in structuring and compiling the extensive Technical Documentation mandated by MDR/IVDR Annex II & III. We ensure completeness, coherence, and readiness for Notified Body scrutiny, covering design, V&V, risk, clinical/performance evaluation, and labelling.
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Technical Documentation Structure Guidance
Ensuring compliance with Annex II and III requirements. -
Clinical/Performance Evaluation (CER/PER) Support
Assistance with strategy, writing, and updates (MEDDEV 2.7/1 rev 4). -
Risk Management File Support
Ensuring alignment with ISO 14971. -
Labelling, IFU & UDI Compliance
Meeting detailed regulatory requirements.
Securing CE Marking and Ensuring Ongoing Compliance
We facilitate your interactions with Notified Bodies during conformity assessment audits and help establish effective Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), and Vigilance systems essential for maintaining your CE mark in the EU.
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Notified Body Strategy & Liaison
Guidance on selection and managing communication. -
Conformity Assessment Audit Preparation
Mock audits and readiness checks. -
Post-Market Surveillance (PMS) System Setup
Developing compliant PMS Plans, Reports, and PSURs. -
Vigilance & PMCF Strategy
Ensuring timely reporting and proactive data collection.
Ready to bring your MedTech innovation to the EU market? We streamline your regulatory journey.