Medical Device Development Services
PPD's clients can accelerate the process of bringing their new medical devices to market with the experience, resources and global reach of our medical device development team. We understand the unique challenges of medical device development: 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 clients' clinical, regulatory and marketing needs.
We dedicate resources to each project, making our teams an extension of our clients' staffs. Linking the teams via a customizable suite of secure, Web-based project management tools guarantees seamless integration. Our full-service support, customized to our clients' needs, and our expertise in multiple therapeutic areas maximize the results.
Clinical Support Solutions
To ensure a project is on time and on budget, PPD's medical device team provides clinical support solutions that include:
- Clinical study design and implementation for maximum results
- Global trial management and monitoring
- Powerful data management and analytical tools for fast, informed decisions
- Technology solutions that expedite submissions with higher quality data
- Unique understanding of combination products based on our extensive experience in drug development
Clinical Regulatory Expertise
Our medical device regulatory compliance staff has more than 30 combined years of U.S. Food and Drug Administration (FDA) experience. Working in partnership with a pre-eminent physician network and experienced consultants, we can provide the highest quality 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
We can also provide clinical regulatory compliance services for medical devices through our European representatives.
