Expertise
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
1st
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