Medical Devices
Medical Device Software Development
FDA-compliant production, quality, and traceability systems for medical device manufacturers.
Our Medical Device Expertise
Solutions for Regulated Manufacturing
Production Management
Device history records, manufacturing workflows, and work-in-process tracking.
Quality Management
CAPA, complaint handling, audit management, and document control.
Device Traceability
UDI compliance, lot tracking, and component genealogy.
Design Controls
Design history file management and verification/validation tracking.
Supplier Management
Approved supplier qualification and monitoring.
Warehouse & Fulfillment
Lot-controlled inventory and compliant shipping documentation.
Compliance
Built for FDA Requirements
21 CFR Part 11
Electronic records and signatures compliance.
IEC 62304
Software lifecycle process documentation.
ISO 13485
Quality management system support.
UDI Compliance
Unique device identification tracking.
Ready to Build Compliant Systems?
Let's discuss your regulatory requirements and manufacturing challenges.