Medical Devices

Our team has a deep understanding of the global regulatory environment and clinical trial requirements for medical devices and diagnostic products.

Our experience includes:

  • Diagnostic Tests
  • Drug-device combination products
  • In vitro laboratory and companion diagnostics (IVD)
  • Diagnostic imaging devices and systems
  • Medical device software, wireless systems, and mobile apps.
  • Bio-engineered and tissue-engineered products
  • Surgical tools, systems, and accessories
  • Drug delivery platforms
  • Implants
  • Wearables
  • Artificial intelligence integrated systems
A Successful Track Record

CSSi LifeSciences has made a difference through expertise and resources to achieve unparalleled industry success.

Over 30 FDA Special Designations granted

Over 250 FDA CDRH Class 1 and 2 medical device submissions with 100% success


Extensive “first-in-class” and “first in” indication experience

Over 65 FDA NDA, BLA, 505(b)(2) successful submissions

Our team’s extensive experience with novel and complex drugs and medical devices includes:

Precision Medicine

Orphan and Rare Diseases

Personalized Medicine

To ensure your project’s success, we are committed to providing:

A single point of contact for all project phases

A strategic, global approach to regulatory planning and product development

Expertise in a wide range of therapeutic indications

Optimized compliance throughout the product lifecycle

A global clinical site network

An integrated ecosystem of support services

Streamline the regulatory process for your medical device