ReadySet ISO 13485 Pricing & Ordering

Deploy your ISO 13485 QMS quickly.

ReadySet provides a structured and ready-to-use framework.

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Download the ReadySet guide to explore the full QMS structure and architecture.

ReadySet ISO 13485 QMS Pricing by Company Size

Company Size	Price (excl. tax)
Startup One organization or legal entity / not a holding/group / maximum 15 employees	€2,600
Scaleup A small holding or group with a maximum of 2 subsidiaries / maximum of 150 employees	€3,900
Entrprise A large holding or group with no maximum subsidiaries and no maximum employees	€5,300

The ISO 13485 QMS price depends on your company size and includes a perpetual license for the QMS ReadySet

This ISO 13485 QMS price includes all the tools needed to deploy your quality system.

How ordering works

Select the plan that matches your company size.

Choose the plan that fits your company’s size.

If you request a proforma invoice:

• Receive the invoice
• Complete the payment
• Receive the paid invoice by email

After payment:

• You will receive an email with access to the ReadySet application and detailed instructions
• Clone the ReadySet workspace into your Confluence instance
• Your ReadySet QMS is ready to use

Frequently Asked Questions

Do I need Confluence to use ReadySet?

Yes, ReadySet allows you to deploy your QMS as a structured Confluence workspace. Using Confluence allows you to fully benefit from the system.

Is this ISO 13485 QMS compliant with regulatory requirements?

Yes, ReadySet provides a structured framework aligned with ISO 13485 processes and documentation requirements. Organizations can adapt the framework to their specific activities and certification scope.

Can I customize ReadySet to my product?

Yes, ReadySet provides a complete ISO 13485 QMS framework. It can be adapted to different medical technologies, including medical devices, IVDs, and Software as a Medical Device. For example, the structure can be tailored to your product type.

Is consulting required?

ReadySet allows you to implement your QMS independently. However, you can request optional expert support if needed.

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