Medical Device Consulting Services fromthoughttofinish

Medical Device Consulting for Global Compliance

Navigating the rapidly evolving medical device regulatory landscape is one of the greatest challenges facing today’s manufacturers and innovators. From product design and verification to clinical evaluation and global market authorization, regulatory alignment is essential to achieving successful and sustained market access.

At ELIQUENT, we provide expert medical device regulatory consulting services designed to guide organizations through complex requirements across FDA, EU MDR/IVDR, MHRA, and other global authorities. Our goal is to strengthen submission readiness, streamline compliance processes, and support the successful approval and lifecycle management of medical devices and combination products.

INFO SHEET: Medical Device & Combination Product Solutions

Medical Device Regulatory Expertise

ELIQUENT’s expertise is built on decades of hands-on experience supporting the regulatory, quality, and technical needs of medical device and combination product manufacturers. Our team includes former regulatory leaders, ex-agency reviewers, quality systems experts, and engineers who bring deep insight into the scientific, clinical, and regulatory dimensions of device development.

  • Unwavering Focus: We prioritize regulatory precision, technical accuracy, and strategic foresight in every engagement. Our experience spans the full medical device lifecycle—from early design and risk classification to technical documentation development, FDA 510(k)/PMA/De Novo submissions, CE marking under MDR/IVDR, clinical evaluation, and post-market surveillance.

  • Years of Experience and Global Reach: WWe bring extensive experience supporting device submissions and regulatory interactions with FDA, notified bodies, MHRA, and global authorities. Our guidance is informed by up-to-date regulatory intelligence, real-world experience addressing agency queries, and a proven track record navigating evolving medical device and combination product requirements.


Why choose ELIQUENT for medical device support?

Selecting the right partner for regulation is critical. ELIQUENT offers key differentiators that drive successful project outcomes:

Deep, Cross-Functional Medical Device Expertise

Our consultants bring extensive hands-on experience across medical devices, diagnostics, and combination products, with deep knowledge of global regulatory frameworks. We support the development and refinement of technical documentation—including Design History Files (DHF), Device Master Records (DMR), Risk Management Files (per ISO 14971), Clinical Evaluation Reports (CER), Performance Evaluation Reports (PER), and labeling—ensuring alignment with FDA, MDR, IVDR, and international requirements.

Global Medical Device Regulatory Track Record

We guide clients through the evolving regulatory expectations of FDA, notified bodies, MHRA, and global health authorities. Our team supports successful submissions including 510(k), PMA, De Novo, Q-Submissions, CE marking under MDR/IVDR, and provides strategic insight to streamline approval pathways across multiple markets.

Integrated Medical Device Regulatory Strategy

We deliver cohesive regulatory strategies that bring together design, clinical, quality, and manufacturing considerations. By integrating regulatory intelligence, risk assessment, and submission planning, we help organizations move efficiently from concept to market—reducing regulatory friction and strengthening overall submission quality.

Scalable Medical Device Regulatory Solutions

From early-stage start-ups preparing their first regulatory submission to global manufacturers managing complex device portfolios, we offer flexible support tailored to product class, risk level, and organizational needs. Our scalable solutions adapt to evolving requirements across the full lifecycle—from development and testing to post-market surveillance and compliance maintenance.

Medical Device Regulatory Services

We offer a comprehensive suite of medical device–focused regulatory services designed to support the full lifecycle of devices, diagnostics, and combination products:

CMC Strategy & Submission Readiness

Developing clear regulatory strategies, preparing and authoring high-quality technical documentation, and supporting FDA and EU submissions across all device classifications. This includes 510(k), PMA, De Novo, Q-Submission packages, CE Marking under MDR/IVDR, and global registrations. We guide clients through device classification, regulatory pathway selection, risk management, clinical/ performance evidence requirements, and interactions with FDA, notified bodies, and other authorities—ensuring readiness for every regulatory milestone from development to post-market.

GxP & Quality Systems Support

Enhancing and maintaining regulatory-compliant quality systems that support device design, manufacturing, and post-market performance. This includes QMS development and optimization (ISO 13485), design control, validation, documentation management, supplier oversight, and audit preparation. We ensure systems meet global regulatory standards, enabling consistent safety, quality, and performance across the device lifecycle.

Risk & Compliance Assessment

Conducting detailed regulatory compliance assessments, gap analyses, and audit readiness checks to identify issues that may impact approval or ongoing compliance. We support clients in resolving regulatory queries (FDA Additional Information Requests, Notified Body Nonconformities, CAPAs), strengthening technical documentation, and building resilient frameworks aligned with ISO 13485, ISO 14971, MDR/IVDR, and other global requirements.

Training & Continuous Improvement

Providing targeted training for regulatory, quality, engineering, and clinical teams on medical device regulations, design controls, technical documentation, evidence requirements, and post-market obligations. We develop and refine SOPs, implement best-practice frameworks, and equip teams with the knowledge and competencies needed to maintain long-term regulatory excellence under FDA, MDR/IVDR, and international guidelines.

Global Solutions

Expertise beyond borders. ELIQUENT Life Sciences delivers integrated regulatory, quality, and safety expertise to help life sciences companies bring innovative products to market and maintain compliance worldwide.

Our premier team of global regulatory experts support markets across the U.S., Europe, and Asia. From early development strategy to post-market oversight, our solutions are designed to meet the unique regulatory, quality, and pharmacovigilance challenges faced by globally regulated companies.

United States

Our experts have shaped the landscape of FDA regulatory policy and strategy for decades. We bring this unrivaled knowledge and unique insight to our work with clients every day. Learn More

Europe

The ELIQUENT team applies their deep and diverse knowledge of European regulations to keep clients in lock step with evolving global standards. With decades of experience in the European market, our team understands the intricacies of the European Medicines Agency and offers tailored solutions to ensure products meet and exceed the needs of our clients.

Asia

ELIQUENT offers regionally specialized solutions for innovators across Asia. Our team of highly specialized experts partner with innovators to develop a synchronized, global go-to-market approach that unlocks the full potential of the Asia market and leverages the strategic advantages of Japan’s regulatory landscape.

Explore ELIQUENT Japan >>

Global Market Expansion

ELIQUENT provides end-to-end solutions that support companies navigating complex global regulations. Whether launching a new product or expanding into new regions, ELIQUENT works with innovators to mitigate risks, streamline approvals, and maintain compliance across evolving regulatory landscapes.

Let’s Strengthen Your Medical Device Regulatory Pathway

Whether you need expert support preparing technical documentation, navigating FDA or EU submissions, or building a robust regulatory strategy for global market access, ELIQUENT is here to help. Contact us today to schedule a consultation and discover how we can optimize your medical device regulatory approach, reduce risk, and accelerate your product’s path to approval.

Ready for regulatory clarity? Contact us.

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