Medical Devices & IVD Devices Industry
Regulatory Strategy & Management
Develop tailored regulatory strategies to support global market access for medical devices and IVDs. Services include device classification, regulatory pathway determination (such as 510(k), De Novo, PMA, or CE Marking under EU MDR/IVDR), and preparation for pre-submission meetings. Strategic planning helps manufacturers align with regional requirements and streamline the product approval process in the U.S., Europe, and beyond.
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Post-Market Surveillance & Compliance
Design and implement post-market surveillance (PMS) programs in compliance with FDA, EU MDR/IVDR, and MDSAP requirements. Services include adverse event and vigilance reporting, complaint handling systems, recall coordination, Periodic Safety Update Reports (PSURs), and Post-Market Clinical Follow-Up (PMCF). Ensure continued safety, performance, and compliance of devices after market entry.
Labeling & Marketing Compliance
Review and develop regulatory-compliant labeling, packaging, and promotional materials. Ensure content accuracy, proper inclusion of Unique Device Identification (UDI), and alignment with device claims and intended use. Services also include localization, language translation, and conformity with regional regulatory requirements, such as FDA’s labeling rules and the EU MDR/IVDR Annex I requirements.
Regulatory Tools & Infrastructure
Implement and manage digital tools and infrastructure to support regulatory compliance efforts. Services include deploying eQMS platforms, document control systems, compliance tracking dashboards, and ready-to-use templates for technical files, risk management, and PMS documentation. Scalable solutions help streamline compliance and improve audit readiness.
Quality Program Improvement & SOP Management
Support the development, enhancement, and maintenance of quality management systems (QMS) in alignment with FDA’s Quality System Regulation (21 CFR Part 820), ISO 13485:2016, and MDSAP audit criteria. Services include SOP development, document control systems, internal audit readiness, CAPA implementation, and regulatory gap assessments to strengthen compliance and operational efficiency.
Virtual Regulatory Staffing Support
Offer flexible regulatory staffing solutions to augment internal teams. Experienced regulatory professionals are available on-demand to assist with documentation, technical file preparation, labeling reviews, regulatory submissions, QMS implementation, and audit support. Ideal for short-term needs, ongoing projects, or scaling regulatory capacity quickly.
Marketing & Sales Material Review
Ensure marketing and promotional content meets global regulatory requirements and is compliant with FDA, EU MDR/IVDR, and other jurisdictional standards. Provide thorough review of websites, digital media, print advertisements, and other materials to confirm claims are substantiated, appropriate for the intended audience, and free from regulatory risk.
Maintain Manufacturing Licenses & Registrations
Provide support for acquiring and maintaining required manufacturing licenses and registrations across jurisdictions. This includes FDA Establishment Registration and Device Listing, state-level licensing, EU Authorized Representative and importer registrations, and ongoing renewal management to prevent disruption in operations or market access.
Training & Regulatory Intelligence
Offer customized training programs for RA/QA and operational teams to ensure compliance with current regulatory requirements and best practices. Stay informed with real-time regulatory intelligence updates covering FDA guidance, EU MDR/IVDR changes, global standards, and enforcement actions. Equip teams to navigate audits and inspections confidently.
Import/Export Compliance Support
Facilitate regulatory-compliant international trade of medical and IVD devices. Services include assistance with FDA import procedures, Prior Notice, customs clearance, and managing detentions. Provide expert support for import permit applications and regulatory documentation for sales teams. Also manage the issuance of Certificates of Free Sale (FSC), Certificates of Exportability (CoE), and Certificates to Foreign Governments (CFG) to enable smooth export operations.
Maintain Manufacturing Licenses & Registrations
Provide support for acquiring and maintaining required manufacturing licenses and registrations across jurisdictions. This includes FDA Establishment Registration and Device Listing, state-level licensing, EU Authorized Representative and importer registrations, and ongoing renewal management to prevent disruption in operations or market access.