Medical Device Development
Medical device trials are unique — we have the experience and expertise to support them
Medical device trials tend to be smaller than drug trials, but they are no less complex. Difficult to blind, randomize and control, they demand specialized experience and the flexibility and expertise to understand how to leverage user feedback to optimize your product.
Our clinical, regulatory and marketing services focus on bringing medical devices to market and then supporting them throughout the life cycle. We dedicate resources to every project, working as an extension of your staff. Our full-service support coupled with our vast expertise across therapeutic areas maximize results.
Specific regulatory experience
Our extensive experience in all classes of medical devices and diagnostics and exacting regulation requirements can help you save time and money. Whether your medical device is targeted to domestic or global markets, we can help you overcome the challenges of an ever-evolving global regulatory environment. With offices in 46 countries, we have the global resources and local regulatory knowledge to facilitate effective strategies for approval.
Working in partnership with a pre-eminent physician network and experienced consultants, we provide FDA regulatory compliance strategy for medical device development, including:
- FDA submissions
- FDA meeting preparation, attendance and follow-up
- Quality assurance auditing and compliance
- Quality system design and assessment
- Employee training and document control
Medical device diagnostic experience
Across the diagnostic device spectrum, our medical device team provides strategic and clinical trial support for new diagnostic devices and indications. Our experience includes simple normal and healthy sample collection and rigorous investigational device exemption (IDE) trials required by the FDA.
We offer substantial experience in device and diagnostic study execution, strong leadership and significant regulatory experience with the Office of In Vitro Diagnostic Device (OIVD) Evaluation and Safety and the Center for Devices and Radiological Health (CDRH).
Medical device therapeutic experience
Our medical device staff is ready to support your pre-market, post-approval and post-market study endeavors throughout the device life cycle. We have experience managing studies across all therapeutic areas and phases (first in man, feasibility, pilot, pivotal and late-stage registries), from single-center feasibility studies to large global multicenter, randomized controlled studies.
Our global medical device experience includes:
- Cardiovascular
- Interventional
- Gene therapy
- Respiratory
- Pulmonary embolism
- Diabetes
- Burns
- Critical care
- Artificial liver
- Aesthetics
- Obesity
- Gastrointestinal
- Women’s health
- Neuromodulation depression
- Anxiety
- Pain
- Neurovascular
- Ophthalmology IOLs
- Lenses
- Orthopedic knee
- Hip
- Shoulder
- Radiofrequency/ablation
- Urology
- Wound care
- Diagnostics pregnancy
- Hepatitis B
- HPV
- Cardiology (HF)
- West Nile
- A & B viruses
- Simple normal and healthy
- Wound (AI)
- Oncology/hematology
In light of the FDA’s medical device directive update adopted in March 2010 and the subsequently published ISO 14155:2011, we have proactively implemented a dedicated service for global medical device safety monitoring (device vigilance) to ensure our customers are meeting global safety standards and regulations. Our safety department utilizes approved SOPs for medical device safety vigilance, complaint handling and device malfunctions.
Post-approval support
We understand the unique challenges of medical device development across the life cycle: intense competition, precise regulatory requirements, and shortened product exclusivity and life cycle. Our highly experienced medical device specialists provide innovative, results-focused support for our customers’ post-marketing needs.
