Medical Device Development Services

Our experience, your success

Accelerate the process of bringing your new product to market with the experience, resources and global reach of PPD Medical Device. 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 development specialists provide innovative, results-focused support for your clinical, regulatory and marketing needs.

Customized resources

We dedicate resources to each medical device development project, making our teams an extension of your staff. Linking the teams via a customizable suite of secure, Web-based project management tools guarantees seamless integration. Our full-service support, customized to your needs, and our expertise in multiple therapeutic areas maximize your medical device development results.

Clinical support solutions

To ensure your medical device development project is on time and on budget, PPD Medical Device provides strategic and clinical trial support for new diagnostic devices and new indications, including:

• 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

Regulatory expertise

The PPD Medical Device regulatory staff has more than 30 combined years of FDA experience. Working in partnership with a pre-eminent physician network and experienced consultants, we can provide the highest quality FDA regulatory 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 international regulatory services through our European authorized representatives.

Market success

Once your product is on the market, PPD provides strategic guidance and innovative solutions to help you achieve your goals for new and established products. Our full range of services designed to promote product adoptions include:

• Post-approval studies and e-registry product support
• Product safety monitoring
• Reimbursement strategies
• Online education and marketing