Product Overview
Regulatory Affairs Consulting
We provide end-to-end global regulatory affairs support for medical device manufacturers across the United States and key international markets. Our services span the complete product lifecycle, including UDI implementation and remediation, design dossier and technical file preparation and updates, FDA 510(k) documentation, and comprehensive support for EU MDR/IVDR conformity assessments. With deep domain expertise across orthopedics, radiology, laboratory equipment, cardiology, and single-use devices, we develop practical, risk-based, and market-focused regulatory strategies tailored to device classification, technology, and intended use.
We support manufacturers commercializing products in both US and OUS markets by establishing and maintaining an integrated Quality Management System (QMS) compliant with ISO 13485 and US FDA 21 CFR Part 820 (QSR/QMSR), and aligned with major global regulatory frameworks, including Health Canada Medical Devices Regulations, Japan PMD Act (PMDA), China NMPA regulations, and Australia TGA requirements. Our expertise further extends to risk management per ISO 14971, GxP requirements, and specialized quality systems for clinical laboratories, R&D centers, and design houses, ensuring ongoing inspection readiness, audit support, and sustainable compliance across regions.
Key Regulatory Affairs Services
– Global regulatory assessment, gap analysis, and regulatory strategy development for US, EU, Canada, Japan, China, and Australia
– UDI implementation, remediation, and lifecycle management, including database submissions to FDA GUDID, EUDAMED, Health Canada, and TGA
– FDA regulatory submissions, including Traditional and Special 510(k), De Novo, and Pre-Market Approval (PMA) dossiers
– EU MDR / IVDR technical documentation, including Design Dossiers, Technical Files, and support for Annex II & III compliance
– Medical device vigilance and post-market reporting, including MDRs, FSCA/FSN support, and global authority communications
– Labeling and Instructions for Use (IFU) development and review in compliance with FDA, EU MDR, ISO 15223-1, and ISO 20417
– Regulatory remediation and inspection support following audits, inspections, warning letters, or authority observations
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