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ISO 13485:2016 & 21 CFR 820 Purchase-To-Own Software
ISO 13485 & 21 CFR 820 Complete Software with all 15 Modules
Software with complete set of 15 modules: Document Library, Forms & Records, Document Control, Training, Change Control, Risk Management, Complaints, CAPAs, NC Product, Products, Internal Audits, Management Reviews, Supplier Control, Mesuring Equipment, Preventive Maintenance
Standard
Edition
Professional
Edition
ISO 13485 & 21 CFR 820 IMSXpress software with 15 modules. Incl. 3 Full users $4,650 $6.200
Pre-loaded ISO 13485:2016 & 21 CFR 820 template documentation: Quality Manual and 40 Operational Procedures (forms are embedded in the software, so no 'paper' forms are included) $760 (nonrefundable) 
ISO 13485:2016 & 21 CFR 820 Internal Audit Checklist (can also use for Gap Analysis) $110 (nonrefundable) 
 
Additional Users
Discounts available for 10 or more Full, Basic or Offline Trainee licenses
Standard
Edition
Professional
Edition
Additional Full User account
(You can change quantity in the shopping cart)
$516 $690
Additional Basic User account
(You can change quantity in the shopping cart)
$258 $345
Additional Offline Trainee account
(You can change quantity in the shopping cart)
$86 $115
Software Validation Report Package
The validation report package includes Validation Plan, Full Validation Report (about 600 pages), Software Release Notice, and Software Validation procedure. The documents are updated for new software versions.
Software Validation Report Package: Validation Plan, Final Validation Report (over 600 pages), Software Release Notice, Software Validation operational procedure
  Annual   $760/year
Database Hosting Service
Hostig your database on Microsoft Azure cloud server, plus backups and other maintenance.
Database Hosting Service: Optional database cloud hosting with online access. Includes daily backups with 7 days retention.
  Annual   $760/year
Maintenance & Technical Support Plan
The M&TS Plan includes updates and technical suppot.
Maintenance & Technical Support Plan billed annually at 15% of the cost of your software and additional users, per current pricing
  Annual 15% value
Upgrade Add-On Modules (for existing systems)
For systems that were purchased before these new modules existed
Standard
Edition
Professional
Edition
Training module:
Fully automated training system with self e-training, integrated document training, job descriptions, and more (Full, Basic or Offline Trainee license is required for each trainee)
$750 $1,000
 Change Control module:
 Use for document, engineering, and process
 changes. Fully integrated with Doc Control module.
$750 $1,000
 Risk Management module:
 Use for ISO 14971 device risk management
 and to manage QMS related risks.
$750 $1,000
Forms/Records module:
Use for making fillable PDF form templates, and for filling the forms with data and creating records.
$750 $1,000
 Preventive Maintenance module:
 Use for scheduling and administrating maintenance,
 and for managing spare parts inventory
$750 $1,000
 Products module:
 For each product (device) track changes, CPAs, complaints, nonconformities, risk management, audit findings, and supplier nonconformities
$750 $1,000
Software Edition Upgrades (for existing systems)
Upgrades are easy to install and completely preserve your data continuity
Software
Upgrade
Full User
Upgrade
Basic user
Upgrade
From: STANDARD edition
To: PROFESSIONAL edition
$1,860 $200/user $100/user
From: LIGHT edition
To: STANDARD edition w/ 3 Full User licenses
$1,320
From: LIGHT edition
To: PROFESSIONAL edition w/ 3 Full User licenses
$2,970
 
Maintenance & Technical Support Plan
Software updates and technical support
For-purchase-to-own software the first year Maintenance & Technical Support plan is included in the initial purchase price. After the first year you need to purchase the annual Maintenance & Technical Support plan at 15% of the cost of your software and additional users, per current pricing above.
If you require a quote, please contact us by phone +1 626 796 9000 or email cs@imsxp.com
For the Subscription option go to the Subscription store.
Remote Online Access
Optional database cloud hosting and maintenance can be purchased as an ad-on service.
Maintenance and
Technical Support
First year Maintenance & Technical Support plan is included in the initial purchase price. After the first year you need to purchase a Maintenance and Technical Support plan (to see pricing, scroll down to the bottom of page).
The differences between the Standard and Professional editions are shown in the Feature Chart.
Full, Basic and Offline Trainee accounts are explained in the User Licenses and Accounts page.
The template documentation package and the internal audit checklist are not refundable.
Note: When you are upgrading from Standard to Professional edition, you need to purchase 'User Upgrade' for the total number of users in your current system. You can adjust the number of users in the shopping cart.