Medical Device Experience

Whether treating chronic heart failure or delivering improved technologies for diabetes and neuromodulation, PHDS has extensive experience managing medical device projects. PHDS 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), from single-center feasibility studies to large global multi-center, randomized controlled studies.

PHDS 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.

PHDS’s global medical device experience includes:

l   Cardiovascular

ü  Interventional

ü  Gene therapy

l   Respiratory

ü  Pulmonary embolism

l   Diabetes

l   Burns

l   Critical care

l   Artificial liver

l   Aesthetics

l   Obesity

l   Gastrointestinal

l   Women’s health

l   Neuromodulation

ü  Depression

ü  Anxiety

ü  Pain

l   Neurovascular

l   Ophthalmology

ü  IOL’s

ü  Lenses

l   Orthopedic

ü  Knee

ü  Hip

ü  Shoulder

l   Radiofrequency/ablation

l   Urology

l   Wound care

l   Diagnostics

ü  Pregnancy

ü  Hepatitis B

ü  HPV

ü  Cardiology (HF)

ü  West Nile

ü  A & B viruses

ü  Simple normal and healthy

ü  Wound (AI)

ü  Oncology/hematology

PHDS’s safety department utilizes approved SOPs for medical device safety vigilance, complaint handling and device malfunctions.