Streamline Your Medical Device Quality with ISOXpress ISO 13485 Standard

ISOXpress (developed by AQA Company Inc., often branded under its parent platform IMSXpress) is a specialized Quality Management System (QMS) software tailored for the medical device industry. It is designed to jump-start compliance with the ISO 13485:2016 international standard and the US FDA 21 CFR Part 820 Quality System Regulation (QSR). 🛡️ Built-in Compliance Architecture

ISOXpress mirrors the actual structural clauses of the ISO 13485 standard. When installed, the software establishes a pre-configured documentation database, baseline forms, and standard operating procedures (SOPs). This structure reduces the time required to build a compliant medical device QMS from scratch. The platform supports key global regulatory frameworks:

ISO 13485:2016: Globally harmonized QMS requirements for medical hardware, software, and components.

FDA 21 CFR Part 11: Fully compliant in its “Professional” edition, featuring electronic signatures, audit trails, and strict data security protocols.

Global Vigilance Rules: Integrated tracking for FDA Medical Device Reporting (21 CFR Part 803) and European Medical Device Vigilance (MEDDEV) frameworks. ⚙️ Core Operational Modules

The system streamlines day-to-day operations through 15 tightly integrated modules:

Document Control: Organizes quality manuals, device master records (DMR), and standard work instructions via automated routing, approvals, and revision controls.

CAPA & Non-Conforming Products: Tracks product flaws and customer complaints through a closed-loop Corrective and Preventive Action system.

Risk Management: Aligns with ISO 14971 to help teams conduct preliminary design risk analysis studies and manage failure mode impacts early in development.

Training & Competency: Features built-in course testing and automatic generation of competency verification records.

Supplier & Asset Control: Manages approved supplier lists (ASL) alongside preventative equipment maintenance schedules and calibration logs. 📈 Business and Audit Benefits ISO 13485 Compliance Streamlines Medical Device Launches