Clients can accelerate the process of bringing their new products to market with the experience, resources and global reach of PPD’s 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 every project, making our medical device development team an extension of our client’s staff. Linking the teams via a customizable suite of secure, Web-based project management tools delivers seamless integration. Our full-service support, customized to our clients' needs, and our expertise in multiple therapeutic areas maximize the results.
Medical Device Regulatory Expertise
PPD’s extensive understanding of the medical device regulatory landscape helps our clients save time and money with their studies. Our medical device regulatory compliance staff has more than 30 combined years of U.S. Food and Drug Administration (FDA) experience and we also have dedicated device regulatory experts in Europe.
Working in partnership with a pre-eminent physician network and experienced consultants, we 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 also can provide clinical regulatory compliance services for medical devices through our European representatives.