Whether treating chronic heart failure or delivering improved technologies for diabetes and neuromodulation, PPD has extensive experience managing medical device projects. PPD understands the unique requirements and regulatory needs of the medical device industry for compliance with national laws, regulations and international standards.
Our medical device staff is ready to support your pre-market, post-approval and post-market study endeavors. We have experience managing studies in all phases (first in man, feasibility, pilot, pivotal and late-stage registries), from single-center feasibility studies to large global multi-center, randomized controlled studies.
PPD understands that medical devices involve a complex mix of engineering and science. Our dedicated device and diagnostic regulatory teams are closely involved in projects, ensuring a thorough review of studies throughout the device life cycle.
PPD’s global medical device experience includes:
- Gene therapy
- Critical care
- Artificial liver
- Women’s health
- Wound care
- Hepatitis B
- Cardiology (HF)
- West Nile
- A & B viruses
- Simple normal and healthy
- Wound (AI)
In light of the U.S. Food and Drug Administration’s medical device directive update adopted in March 2010 and the subsequently published ISO 14155:2011, PPD has proactively implemented a dedicated service for global medical device safety monitoring (device vigilance) to ensure our clients are meeting global safety standards and regulations. PPD’s safety department utilizes approved SOPs for medical device safety vigilance, complaint handling and device malfunctions.
Contact us to learn more about our complimentary ISO 14155:2011 training.