What is ISO 13485 Quality Management?
IMSXpress is a sophisticated platform tailored for the administration of document control, the assurance of regulatory compliance, and the management of quality systems in accordance with ISO 13485 and FDA 21 CFR part 820 regulations. It includes a range of features such as document distribution, control, CAPA management, complaint resolution, auditing, training oversight, MDR processes, supplier management, and tracking of non-conforming products. This cutting-edge software is available for either local installation or cloud deployment, and it comes with a variety of pre-built template manuals, procedures, employee training resources, and audit checklists to facilitate a smooth implementation process. Furthermore, its user-friendly interface significantly improves the overall experience, making the management of compliance more streamlined and effective than ever before. Consequently, organizations can ensure they remain up-to-date with regulatory demands while enhancing their operational efficiency.
Pricing
Price Starts At:
$1460.00/one-time
Free Trial Offered?:
Yes
Integrations
No integrations listed.
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ISO13485QualityManagement-Complaints
Company Facts
Company Name:
AQA
Date Founded:
1992
Company Location:
United States
Company Website:
www.imsxp.com
Product Details
Deployment
SaaS
Windows
Training Options
Documentation Hub
Webinars
Support
Standard Support
Product Details
Target Company Sizes
Individual
1-10
11-50
51-200
201-500
501-1000
1001-5000
5001-10000
10001+
Target Organization Types
Mid Size Business
Small Business
Enterprise
Freelance
Nonprofit
Government
Startup
Supported Languages
English
ISO 13485 Quality Management Categories and Features
Compliance Software
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation