Our U.S. regulatory team—featuring over 25 former FDA managers and reviewers—provides support for 510(k), De Novo 510(k), PMA, and Q- submissions including breakthrough submissions. We help clients engage with the FDA, develop strong submissions, and provide actionable feedback to accelerate compliant U.S. market access.
Our EU and UK regulatory team— including former Notified Body reviewers—guides clients through EU MDR, EU IVDR, and UKCA requirements. We support strategy, gap analysis, technical documentation, and notified body engagement to streamline submissions and secure timely certification.
Our bilingual, local teams help MedTech innovators manage complex APAC regulations with tailored strategies for each market. In Japan, we support Shonin applications and provide D-MAH services alongside regulatory planning to enable compliant market entry.
We partner with innovators to navigate diverse regulatory frameworks across LATAM and other regions. Leveraging local expertise and global coordination, we design country-specific regulatory strategies to streamline submissions and unlock new market opportunities.
IQVIA MedTech’s medical device regulatory consulting starts with a focused landscape assessment to inform global regulatory strategy. Our experts deliver tailored medical device regulatory services that align clinical, regulatory, and payer pathways for faster approvals and market success.
IQVIA MedTech’s medical device regulatory consulting is powered by advanced technologies that streamline compliance and accelerate innovation. Our cloud-based platforms and AI-driven tools deliver real-time insights, optimize workflows, and support regulatory success across global markets.
IQVIA MedTech supports medical device readiness—spanning safety, security, usability, and software performance—as integrated components of a robust regulatory strategy. Our experts help address biological safety, cybersecurity risk, human factors, and software expectations, aligning design, risk management, and documentation with global regulatory requirements across the product lifecycle.
IQVIA MedTech’s medical device regulatory services extend beyond approval, supporting long-term medical device regulatory compliance through proactive post-approval strategies. Our experts help manage risk, maintain safety, and adapt to evolving global requirements.
Preparing for U.S. regulatory submissions requires early engagement, clear strategy, and a strong understanding of FDA expectations. Support from teams with firsthand agency experience can help companies develop submission ready documentation, navigate feedback efficiently, and make informed decisions across 510(k), De Novo, PMA, and Breakthrough pathways.
IQVIA MedTech’s FDA Regulatory Advisory team—including former FDA staff—guides clients through 510(k), De Novo, PMA, and Breakthrough submissions, providing direct engagement support and comprehensive submission preparation.
European and UK market access requires careful planning around evolving regulatory frameworks, technical documentation, and notified body engagement. Effective support includes gap analysis, strategic submission planning, and coordination with reviewing authorities to streamline certification and reduce delays under EU MDR, IVDR, and UKCA requirements.
IQVIA MedTech assists with MDR, IVDR, and UKCA submissions, offering technical documentation, clinical and performance evaluation planning, and notified body engagement for efficient European and UK market access.
Global expansion often involves navigating diverse regional requirements while maintaining consistency in regulatory strategy. Successful approaches combine local, in country expertise with global coordination to support country specific submissions, harmonize documentation where possible, and manage complexity across APAC, LATAM, Japan, and other international markets.
IQVIA MedTech provides regulatory expertise for Japan, APAC, LATAM, and other regions, tailoring strategies to local requirements and harmonizing submissions for global market entry.
Early alignment across regulatory, clinical, and reimbursement planning helps reduce rework, clarify evidence needs, and support downstream access. Considering how regulators, payers, and other stakeholders assess value enables more informed decisions earlier in development and supports a smoother path from submission to approval and beyond.
IQVIA MedTech develops integrated strategies that align regulatory, clinical, and reimbursement pathways, considering the expectations of the various reviewing parties, and ensuring efficient approvals and successful market access for new technologies.
Modern regulatory strategy is increasingly supported by advanced technology. Cloud based Regulatory Information Management (RIM) and Quality Management System (QMS) platforms, regulatory intelligence tools, and AI enabled automation can improve visibility, streamline workflows, and help teams manage compliance across global regulatory requirements more efficiently.
IQVIA MedTech provides advanced regulatory technology, including RIM systems, AI automation, QMS platforms, and compliance dashboards to streamline global regulatory processes and enhance visibility.
Maintaining compliance after approval requires proactive lifecycle management as regulations, risks, and product use evolve. Ongoing support can include post market surveillance, safety monitoring, regulatory reporting, and quality activities that help sustain compliance while adapting to global regulatory changes.
IQVIA MedTech offers ongoing support for safety monitoring, real-world data collection, adverse event reporting, recalls, field actions, and quality assurance to help maintain global compliance after market entry.
