A legacy of medical device innovation
With a pedigree spanning all device types and major therapeutic areas, we deliver strategic, regulatory, nonclinical, manufacturing, quality, clinical, and commercial expertise.
Elevating device development from concept to market
Whether you’re on the ground floor of product design or on the precipice of a 10,000-patient post-marketing surveillance study, we understand the challenges and opportunities in the heights you aim to scale. Our experience bridges every stage of development and just about every type of device, from transcatheter heart values to dermatologic devices and everything in between.
Many members of our medical device team have roots in manufacturing, so we know where to dig with our questions: What endpoints will global regulatory bodies expect? Which indication and claims offer the best return on investment? What about pricing and qualifying for separate reimbursement? Our experts guide you in answering these questions and traversing today’s dynamic and occasionally disorienting regulatory and reimbursement terrain.
We understand the differences among categories of medical devices, and our regulatory team advises on the latest global policy shifts and regulatory requirements, from CE marking to EU Medical Device Regulation (MDR)/In Vitro Diagnostic Device Regulation (IVDR).
Perceptive collaboration throughout the entire development lifecycle
| Concept & Validation | Planning & Program Gap Analysis | Efficacy Evidence | Regulatory & Pre-launch | Commercialization |
|---|---|---|---|---|
| Discovery and Planning | Request for Designation (RFD) | Pivotal Clinical Studies | Regulatory & Market Access | Post-Approval |
Best-in-class expertise across devices, indications, and geographies
- Deep background in device types, including companion diagnostics, wearables, software as a medical device, and combined device/biologic.
- Broad experience across major therapeutic areas, including cardiovascular, neurology, gastroenterology, orthopedics, and other specialty areas.
- Global regulatory expertise with a firm grasp on the challenges of complying with evolving requirements such as MDR and IVDR.
Meet the Experts
Medical Device
Heidi Boehm
Michael Edwards
John Thomas, M.Sc.
Frank Keulen, M.Sc.
Suzanne Courtney
Nicole Sativtsky
Nach Davé
Insights
Agility and knowledge at your fingertips
4 Scenarios When High Risk Devices May Be Exempt from Mandatory Clinical Investigations Under EU MDR
Conducting Clinical Studies Under an Investigational Device Exemption
FDA’s LDT Proposal and Its Impact on Clinical and Regulatory Professionals
Getting the Support You Need at Every Step of the CE Marking Process
resources
Stay ahead of the curve by browsing our extensive library of white papers, case studies, blog posts, and more.
Ready to get started? So are we.
Drop us a line to learn more about how we can help.