Navigating complexity with clarity: Hogan Lovells’ global approach to medical device innovation

Bringing a medical device to market is rarely straightforward. From early-stage design and regulatory approval to commercialisation and postmarket compliance, each step requires navigating a complex web of global regulations. Hogan Lovells, one of the world’s leading law firms in the life sciences sector, has built a reputation for helping companies move through these challenges with precision and foresight.
With years of experience advising on FDA regulations and medical technology law, Hogan Lovells’ Medical Device and Technology practice works with innovators across every major health market. The firm’s approach combines scientific insight, regulatory depth, and strategic coordination across jurisdictions to help clients bring products to patients faster and more securely.
“We are committed to helping companies turn regulatory challenges into opportunities,” said Jodi Scott, Partner at Hogan Lovells. “Our team understands the science behind each product, which allows us to develop strategies that not only meet regulatory expectations but also support long-term business objectives.”

“Whether it’s obtaining FDA clearance, ensuring compliance, or designing a postmarket strategy, our goal is to help clients stay ahead of the curve in an evolving global landscape.”

A track record of firsts

The firm’s work spans groundbreaking approvals and novel regulatory pathways. Hogan Lovells advised Bioretec Ltd. in securing FDA authorisation for the RemeOs trauma screw, the first bioresorbable metal implant approved in the United States. This milestone not only advanced orthopedic innovation but also demonstrated the firm’s ability to guide clients through complex de novo submissions.
In recent years, Hogan Lovells has also supported AI-driven diagnostics, digital health applications, and next-generation combination products. The team has been instrumental in helping clients obtain expedited review status for novel technologies in oncology, cardiology, and women’s health. Its involvement in more than 120 FDA 510(k) clearances and 40 de novo submissions in a single year reflects the team’s extensive regulatory reach and high success rate.
Beyond premarket strategy, Hogan Lovells assists clients with postmarket compliance, recalls, and global quality system audits. The firm’s regulatory and enforcement professionals help companies address FDA observations, Warning Letters, and notified body nonconformities while developing robust corrective action plans. Its integrated approach ensures that companies maintain operational continuity while meeting regulatory expectations in the United States, the European Union, and other key markets.

Expertise grounded in science

What distinguishes Hogan Lovells’ Medical Device and Technology practice is its multidisciplinary expertise. Many of its lawyers have backgrounds in biomedical engineering, medicine, genetics, and materials science, along with prior experience at regulatory agencies such as the U.S. Food and Drug Administration. This scientific grounding enables the team to engage regulators in meaningful discussions and advocate effectively for clients developing emerging technologies.
“Understanding how technology works is essential to shaping the right regulatory path,” noted John Smith, Partner at Hogan Lovells.

“Our experience on both the legal and scientific fronts allows us to anticipate how agencies will view innovation, which helps clients make informed decisions early in the product development cycle. We see our role not just as legal advisors, but as partners in innovation.”

The firm’s areas of focus extend across the medical technology spectrum, including digital health, artificial intelligence, in vitro diagnostics, cell and gene therapies, and combination products. Hogan Lovells has been at the forefront of advising on FDA and EU frameworks for AI-based medical devices, helping companies navigate novel questions around algorithm updates, software validation, and cybersecurity.

A global network, a unified vision

Operating across all major medical markets, Hogan Lovells ensures that regulatory strategies are aligned globally. The firm’s offices in the United States, Europe, Asia, and the Middle East collaborate seamlessly to manage approvals, compliance programs, and commercial agreements across jurisdictions. This global coordination is particularly valuable for multinational clients managing complex supply chains and distribution models.
In addition to its regulatory and compliance work, the firm advises clients on financing, mergers and acquisitions, and IPO readiness, ensuring that regulatory diligence aligns with investor expectations. Its involvement in high-profile transactions demonstrates how legal, regulatory, and business expertise can come together to support sustainable growth in MedTech.

Guiding the future of MedTech regulation

Hogan Lovells’ leadership in medical device law continues to be recognised globally. The firm holds Band 1 rankings in Chambers USA, Chambers Global, and Legal 500 for medical devices and life sciences regulatory work. Its lawyers regularly advise on policy development, regulatory modernisation, and the implications of emerging technologies such as AI and digital therapeutics.
As the MedTech industry continues to evolve, Hogan Lovells remains focused on ensuring that innovation reaches patients safely and efficiently. With a team that combines technical knowledge, legal acumen, and strategic insight, the firm continues to play a central role in guiding companies through one of the most complex regulatory environments in the world.
“Every innovation we help bring to market represents a step forward in patient care,” said Scott. “Our mission is to ensure that these advances are realised responsibly, efficiently, and in full alignment with global regulatory expectations.”

Join MedTech World events in 2026

MedTech World continues to bring together innovators, regulators, clinicians, investors, and industry leaders contributing to the next decade of medical technology. If you would like to be part of upcoming global events, whether as an attendee, speaker, exhibitor, or partner, registration for MedTech World 2026 opportunities is now open.

Those interested in showcasing their work or expanding their network within the MedTech ecosystem can secure their place early by registering now.