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ISO 13485 Quality Management Logo

Compliance Solution for ISO 13485 and CFR part 820

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ISO 13485 Quality Management - 2026 Pricing, Features, Reviews & Alternatives

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Last updated: March 2026

ISO 13485 Quality Management overview

What is ISO 13485 Quality Management?

IMSXpress is a cloud-based regulatory compliance and document control system for managing ISO 13485 and 21 CFR part 820, or equivalent quality systems. It offers end-to-end solution that provides document control, audit checklists, CAPAs, complaint management, training, supplier control, and much more. The software comes preloaded with templates for manual and procedures, audit checklists and employee training booklets.

Starting price

1460per user

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Rating breakdown
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ISO 13485 Quality Management's features

Archiving & retention
Audit management
Audit trail
FDA compliance
ISO compliance
Risk management
Training management
Version control

ISO 13485 Quality Management alternatives

ISO 13485 Quality Management logo

Starting from

1460

/user

One-time payment

Free trial
Free version
Ease of Use
Features
Value for Money
Customer Support

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No pricing info

Free trial
Free version
Ease of Use
Features
Value for Money
Customer Support

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No pricing info

Free trial
Free version
Ease of Use
Features
Value for Money
Customer Support

Starting from

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No pricing info

Free trial
Free version
Ease of Use
Features
Value for Money
Customer Support

ISO 13485 Quality Management pricing

Value for money rating:

Starting from

1460

/user

One-time payment

Pricing details
Subscription
Free trial
Free plan
Pricing range

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ISO 13485 Quality Management support options

Typical customers

Freelancers
Small businesses
Mid size businesses
Large enterprises

Platforms supported

Web
Android
iPhone/iPad

Training options

Documentation
Webinars

ISO 13485 Quality Management FAQs

Q. Who are the typical users of ISO 13485 Quality Management?

ISO 13485 Quality Management has the following typical customers:
Freelancers, Mid Size Business, Small Business

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Q. What languages does ISO 13485 Quality Management support?

ISO 13485 Quality Management supports the following languages:
English


Q. Does ISO 13485 Quality Management offer an API?

No, ISO 13485 Quality Management does not have an API available.

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