Regulatory Affairs
The regulatory environment for medical devices changes rapidly and impacts the entire product life cycle. Physio-Logic provides the regulatory consulting services that medical device companies need to maintain their competitive edge.
We help companies optimize the development process and the regulatory pathways for quickly bringing new devices to market and keeping them there for commercial success.
Our team’s experience extends across a wide range of device types, including device/drug/biologic combination products. It also extends across various types of companies from start-ups to long-established organizations.
With our extensive experience we provide comprehensive support and medical device expertise with:
  • Strategic planning and regulatory consulting
  • Risk Management program development and implementation
  • Medical Device product design history file compliance
  • Medical Device standards assessment
  • CE Certification
  • Preparation of draft IDE submissions, including protocol summary
  • Participation in pre-IDE interactions with FDA
  • FDA submissions: IDE, PMA and 510K
We have a reputation for regulatory problem solving and a history of reversing FDA class III designation and negotiating least burdensome clinical trial design for our clients.