Novel Technologies
IP strategy and materials science applied to next-generation diagnostic and therapeutic devices.
Medical Devices
We help medical device teams navigate design controls, quality management systems, and regulatory filings — from concept through 510(k) or CE submission. Our GMP-compliant manufacturing and equipment qualification (IQ/OQ/PQ) support reliable, auditable device production at scale. Intelligent information management keeps your Design History File and regulatory documentation fully traceable.
Capabilities
Relevant Capabilities
How The 100 World's four pillars apply to medical devices.
Product Development
Design controls and Design History File (DHF) management aligned to ISO 13485 and FDA QSR.
GMP Manufacturing Solutions
Quality management systems and equipment qualification engineered for device manufacturing reliability.
Intelligent Information Management
Regulatory filing support and traceable documentation for 510(k) and CE submissions.
Ready to discuss your Medical Devices project?
Let's talk about how The 100 World can move your medical devices innovation from concept to compliant, commercial-ready product.