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ISO 13485 Quality Management

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About ISO 13485 Quality Management

ISO 13485 Quality Management is a software platform from AQA designed to simplify quality management processes specifically for the medical device industry. It includes features such as document control, risk management, audit management, and training management so users can ensure compliance with international quality standards and improve operational efficiency. The platform is user-friendly, allowing teams to easily access and manage important quality documents and records. Key capabilities: - Document Control - Risk Management - Audit Management - Training Management - Reporting and Analytics Best for: Medical device manufacturers and suppliers that need to maintain compliance and improve their quality management systems.

ISO 13485 Quality Management Details

Vendor
AQA
Year Launched
Location
Geneva, Switzerland
Deployment
Training Options
demo, account manager, community
Countries Served
All Countries
Languages
English, French, Spanish, German, Italian, Chinese, Japanese, Korean, Portuguese, Russian.
Users
Quality Manager, Compliance Officer, Regulatory Affairs Specialist, Quality Assurance Engineer
Industries Served
Healthcare, Medical Devices, Pharmaceutical, Manufacturing, Aerospace
Tags
ISO 13485, Quality Management, Compliance, International Organization for Standardization, Standards, Medical Devices, Healthcare industry

ISO 13485 Quality Management's In-App Market Place

Does ISO 13485 Quality Management have an in-app market place?

Yes

How many Mini-Apps in the marketplace?

14

Mini Apps

1. ComplianceQuest: A compliance management platform that integrates with ISO 13485 to streamline compliance processes and keep track of regulatory requirements.

2. Qualio: A quality management system add-on for ISO 13485 that helps companies manage documents

training

audits

and non-conformities.

3. Greenlight Guru: A quality management software specifically designed for medical device companies adhering to ISO 13485 standards. It helps companies manage design controls

risk management

and supplier quality.

4. MasterControl: A quality management system that integrates with ISO 13485 to automate and streamline document control

change control

and training processes.

5. AssurX: A compliance management software that integrates with ISO 13485 to help organizations manage quality processes

audits

and corrective actions.

Pricing Options

Free trial
Free version
Request a quote
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Accepted Payment Currencies

USD ($), EUR (€), GBP (£), AUD (A$), CAD (C$), JPY (¥), CHF (Fr), CNY (¥), SEK (kr), INR (₹), BRL (R$)

Pros & Cons

  • Helps organizations comply with ISO 13485 standards
  • Streamlines quality management processes
  • Improves product quality and safety
  • Enhances overall efficiency and productivity
  • Reduces the risk of product recalls and quality issues
  • Demonstrates commitment to industry standards and regulations
  • Steep learning curve for users unfamiliar with quality management systems
  • Limited customization options for specific industry or company needs
  • High cost of implementation and maintenance
  • Lack of integration with other software systems, leading to data duplication and inefficiencies
  • Difficulty in tracking and documenting changes, leading to potential compliance issues
  • Lack of robust reporting capabilities, making it challenging to analyze data effectively

ISO 13485 Quality Management's Support Options

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