Medical Device & Diagnostics
Ensuring proper planning throughout the medical device development process, from first-in-human to post-market surveillance.
Helping you optimize your medical device’s development pathway
Whether you’re conducting a 10-patient feasibility study or a 10,000-patient post-marketing surveillance study, we know all the steps — from scientific breakthrough to successful outcomes. Our experience spans just about every type of device, from transcatheter heart valves to dermatologic devices and everything in between.
Many members of our medical device team come from manufacturers, so they know which questions to ask: What endpoints will global regulatory bodies expect and approve? What indication provides the best return on investment? Which claims make sense? What about pricing, and ensuring that your device qualifies for separate reimbursement?
We understand the differences among categories of medical devices, and our regulatory team tracks the latest global policy shifts and regulatory requirements.
Supporting the Device Journey
- Regulatory Affairs
- Regulatory submissions (510(k), De Novo, CE Marking, PMA)
- Agency meetings
- Regulatory writing
- Labeling support
- Project management
- Publishing services
- Product development strategy
- Competitive intelligence
- Using regulatory, clinical, quality, and HECON to develop product development plans
- Product licensing and acquisition due diligence services
- Quality Systems
- Quality management system strategy
- QMS set-up and compliance to ISO 13485
- Remediation programs
- Risk management
- SOP drafting and review
Guidance for combination products
These documents clarify best practices for communication during interaction with the agency. They provide a framework for identifying gaps in development programs that may result from the unique properties of the combination product.
Best practices for device trials in Asia
Reviewing best practices for cardiovascular medical device development in Asian countries can offer insights on traversing the regulatory and clinical landscape of this region.
Clinical Development Expertise for Combination Studies
When you’re developing a combination product, therapeutic experience has no substitute. Unlike CROs who focus solely on device studies, we supplement our device expertise with extensive clinical development experience across therapeutic areas. See what we’ve been busy doing for the past five years.
- Cardiovascular Device Indications
- Transcatheter aortic valve transplantation (TAVI)
- Heart valve replacement and repair (both aortic and mitral)
- Mechanical reperfusion device (bare metal and drug-eluting stents)
- Thoracic endoprosthesis and stent
- Drug-eluting balloon
- Catheter (laser and drug-eluting)
- Cardiac assist devices
- PFO closure devices
- EP – ablation systems
- CRT devices
- Baroreflex stimulator cardiac pressure monitoring devices
- Antimicrobial swabsticks
- Dermal filler
- Neuromuscular blocker, botulinum toxin (onabotulinumtoxinA)
- MT10109L (NivobotulinumtoxinA)
- In vitro diagnostic
- Autologous chrondrocyte implant system
- Injectable disc nucleus
- Interbody fusion
- Integrated knee system
- In vitro diagnostic – rheumatoid arthritis
- IVD – myeloproliferative disorders
- Surefire® Infusion System – liver metastases