AQA Co.

PO BOX 1447
La Canada, CA 91012-5447

About AQA Co.

AQA Company develops quality management software designed specifically for medical device companies. The software complies with US, Canadian and Australian regulations. It is formally validated to FDA, ISO and IEC requirements and complies with 21 CFR Part 11(Electronic Records and Electronic Signatures). We have added 4 new modules, Automated Training, Preventive Maintenance, Change Control and Risk Management module. The Training module will automatically generate and post new/revised document training courses. Automatically generate and post of other training courses (self-study, class and job training). Assign and schedule employees/groups to document training and other training programs. The Preventive Maintenance module has spare parts inventory management and will automatically generate maintenance work orders. The Risk Management module has two different ways to to calculate risk, you choose which is best suite for your device.

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Products by AQA Co.

By AQA Co.

ISOXpress 14971 Medical Device Risk Management software is a Windows application for implementing Risk Analysis, Risk Evaluation, and Risk Control in strict compliance with the ISO 14971:2007 standard. Risk analysis, risk evaluation, and risk control methodologies strictly follow requirements of... Read more »

By AQA Co.

Everything You Need to Jump-start Your ISO 13485 Project As soon as you install the software most of your new quality system is automatically implemented. You can immediately start editing and controlling your documents, initiate corrective actions, process customer complaints, and so forth. The... Read more »