Together, we can help you overcome the unique challenges medical device development presents. As your partner, we can guide you through the ever-changing landscape of regulatory measures, new technologies, and healthcare economics.
We bring the disciplined approach that characterizes successful product development paths, thoughtful regulatory, economic and development strategies, and a meticulous approach to clinical trial execution.
From device classification through to market surveillance on your approved product, our experts work to mitigate risk by navigating applicable regional or global regulations.
Medical Device Services
Our global CRO development and commercial services can advance your medical device from development to deployment in the market.
Development and Testing
Your ultimate resource, we have the specific expertise and experience essential to developing and testing medical devices.
As your full-service, global CRO, our knowledge can guide your project from the initial design stages through the clinical trials and every step of the way, including preparing and filing regulatory documents.
As medical equipment manufacturers, we can ensure that products and medical instruments are fully vetted and verified as safe and effective.
Clinical investigation management
Protocol development and study design
Site monitoring services
Drafting investigational plans
Data collection, management and analysis
Development of the vigilance system
Statistical analysis and reporting
Regulatory consulting and strategy
Preparation of all essential regulatory documents
Regulatory filing and publications
Communication with regulatory authorities and ethics committees
EU Authorized Representative
CE Marking
We can help you to get the CE marking that is essential for marketing medical devices in the European Union. In fact, our experience in this area is some of the best in the industry, making us the top choice for medical device manufacturers wanting to market their products overseas.
To help ensure medical devices for sale in the EU conform to all requirements, we can help with:
RA/QA Consulting
EU Medical Device Classification
EU Authorized Representative
Compilation of Technical Documentation
Clinical Evaluation Reports
Post-marketing surveillance
ISO 13485 Implementation
Development and Testing
- Laser systems for glaucoma
- Minimally invasive glaucoma shunts (MIGS)
- Influenza vaccine/device combination
- Advanced macular degeneration monitoring device
- Diabetic retinopathy AI software
- Reagents for ex-vivo T-cell depletion for GVHD
- Drug coated balloon PTA catheter for treatment of dysfunctional native and synthetic AV fistulae
- Systems for treatment of symptomatic drug-refractory paroxysmal atrial fibrillation
- Systems in patients with central sleep apnea
- Tempered infusions for induction and maintenance of normothermia in refractory febrile patients
- Catheter ablation vs. standard treatment for left ventricular dysfunction and atrial fibrillatione
As a medical devices company, you benefit from our industry-leading qualifications,
dedication to the highest standards of clinical safety and vigilance, and long experience of
developing and testing everything from medical alert devices to implantable technology.
We have completed more than 2,000 clinical studies since 1977, and our knowledge
base covers a broad range of therapeutic areas. We share the private and public sector
industry knowledge we have accumulated to best serve our clients.
Request a Meeting
Connect with our Medical Devices team to learn more.
Factsheet
Medical Devices Factsheet