ISO 13485 Quality Management
ISO 13485 Quality Management by IMSXpress is a cost-effective software for managing ISO 13485 and FDA 21 CFR Part 820 compliance. It offers tools for document control, CAPA, complaints, audits, and training, and comes with templates and guides. Available as a local install or cloud-hosted solution.
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ISO 13485 Quality Management Overview
ISO 13485 Quality Management by IMSXpress is a comprehensive compliance and quality system software designed to support medical device manufacturers in meeting ISO 13485 and FDA 21 CFR Part 820 requirements. It includes robust modules for document control, CAPA, complaint handling, MDR reporting, audits, training, supplier management, and nonconforming products. The system comes preloaded with customizable templates, audit checklists, and employee training guides, making implementation straightforward. Available as both a local install and with cloud hosting, the platform delivers powerful functionality at an affordable price, helping organizations streamline compliance and quality assurance processes.
Features
Comprehensive Quality Management Modules
Preloaded Templates and Documentation
Regulatory Compliance and Validation
Flexible Deployment Options
ISO 13485 Quality Management Pricing Overview
ISO 13485 Quality Management Score
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FAQs
IMSXpress is a Regulatory Compliance, Document Control, and Quality System Management software designed to operate ISO 13485 and FDA 21 CFR part 820 quality systems. It includes modules for Document Control, CAPA, Complaints, MDR, Audits, Training, Supplier Control, Nonconforming Products, and more.
Yes, IMSXpress is designed to cater to organizations of all sizes, from small businesses to large enterprises, across various industries. Its modular design allows for scalability and customization based on organizational needs.
While the primary language is English, it’s advisable to check with the provider regarding support for other languages.
Yes, the platform offers customizable templates and workflows to align with an organization’s specific compliance requirements. However, some users have noted constraints in tailoring certain aspects to fit specific organizational requirements.
IMSXpress offers customer support to assist users with any issues or questions. For detailed support options, it’s best to contact the provider directly.
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