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ISO 13485:2016 & 21 CFR 820 Complete Starter Package
  • Document Control and QMS Management Software (13 modules)
  • QMS Template Documentation (Quality Manual + 39 Procedures + Forms)
  • Internal Audit and Gap Analysis Checklist
  • Employee Training Booklets
SaaS Subscription Software + Starter Package
Includes cloud database hosting with online access
Billing Cycle Standard
Edition
Professional
Edition
 ISO 13485 & 21 CFR 820 IMSXpress Software
 w/ 3 Full User accounts and cloud hosting (SQL DB)
 & Complete Starter Package
  Annual $104/month $165/month
  Monthly $125/month $199/month
 
 Add-on ISO 14971 Risk Management Module
 (use also to comply with ISO 13485:2016
 risk management related requirements)
  Annual $33/month $41/month
  Monthly $39/month $49/month
 
Additional Full User account
(You can change quantity in the shopping cart)
  Annual $22/month $29/month
  Monthly $26/month $35/month
 
Additional Read-Train User account
(You can change quantity in the shopping cart)
  Annual $11/month $15/month
  Monthly $13/month $18/month
 
Remote Desktop Access
(For Mac Computers)
  Annual $15/month
  Monthly $18/month
SaaS Subscription includes:
  • SQL database cloud hosting
  • Online access from anywhere
  • Unlimited maintenance and technical support
The differences between the Standard and Professional editions are shown in the Feature Chart.
Full, Read-Train and Train-Records-Only accounts are explained in the User Licenses and Accounts page.
Purchase-to-own Software + Starter Package
Purchase software and install on your own system (optional Database cloud hosting available)
Light
Edition
Standard
Edition
Professional
Edition
 ISO 13485 & 21 CFR 820 IMSXpress Light Software
 for single computer installation (1 user on 1 computer)
 & Complete Starter Package
$1,490
 ISO 13485 & 21 CFR 820 IMSXpress Software (File Database)
 with 3 Full User licenses
 & Complete Starter Package
$2,490 $3,990
 ISO 13485 & 21 CFR 820 IMSXpress Software (SQL Database)
 with 3 Full User licenses
 & Complete Starter Package
$2,990 $4,490
 Add-on ISO 14971 Risk Management Module
 (use also to comply with ISO 13485:2016
 risk management related requirements)
$690 $990
 
Additional Full User - 1 user license (enter qty in shopping cart) $360 $490
Additional Full Users - 5 user licenses packet $1,620 $2,205
Additional Full Users - 10 user licenses packet $3,060 $4,165
Additional Full Users - 20 user licenses packet $5,760 $7,840
Additional Read-Train User - 1 user license $180 $245
Additional Read-Train Users - 10 user licenses packet $1,620 $2,205
Additional Read-Train Users - 30 users licenses packet $4,050 $5,510
Additional Read-Train Users - 100 users licenses packet $9,000 $12,250
Additional Train-Records-Only User - 1 user license $60 $82
Additional Train-Records-Only Users - 10 user licenses packet $540 $735
Additional Train-Records-Only Users - 30 users licenses packet $1,350 $1,837
Additional Train-Records-Only Users - 100 users licenses packet $3,000 $4,084
 
 
Billing Cycle First GB Additional GB
Database Hosting Service: optional database cloud hosting with online access (available only for SQL Server Database software)   Annual $40/month $20/GB/month
  Monthly $49/month $25/GB/month
Remote Online Access
Optional database cloud hosting service is available for SQL Server Database software
Maintenance and
Technical Support
First year Maintenance & Technical Support plan is included in the initial purchase price. After the first year you can purchase an optional 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, Read-Train and Train-Records-Only accounts are explained on the User Licenses and Accounts page.
Software Upgrades
Upgrades are easy to install and completely preserve your data continuity
Software
Upgrade
User
Upgrade
Read-Train user
Upgrade
From: STANDARD edition
To: PROFESSIONAL edition
$1,700 $130/user $65/user
From: LIGHT edition
To: STANDARD edition w/ 3 Full User licenses
$1,200
From: LIGHT edition
To: PROFESSIONAL edition w/ 3 Full User licenses
$2,700
From: File Database Software
To: SQL Server Database Software
$590
Part 11 electronic records/signatures upgrade $990
Add-on Module: Automated Training module
with Document Training integration
$990
Add-on Module: Preventive Maintenance module $690
Add-on Module: Change Control module $890
Add-on ISO 14971 Risk Management Module
(use also to comply with ISO 13485:2016
risk management related requirements)
$990
ISO 13485:2016 Template Documentation:
Quality Manual, Operational Procedures,
Audit Checklist and Training Booklets
$490
 
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.

Maintenance & Technical Support plan (applies only to Purchase-to-own software)
Automatic software updates and unlimited technical support
First year Maintenance & Technical Support plan is included in the initial purchase price.
After the first year you have the option to purchase the annual Maintenance & Technical Support
plan at the rat of 15% of the value of your software. The software value is calculated
as the current cost of the software + upgrades + additional users.
Please call or email for a quote (phone: 626 796 9000 email: cs@imsxp.com)