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ISO 13485:2016 & 21 CFR 820 SaaS Subscription 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
Billing Cycle Standard
Edition
Professional
Edition
ISO 13485 & 21 CFR 820 IMSXpress software with complete set of 15 modules. Incl. 3 Full users and cloud database hosting.   Annual $165/month $245/month
  Monthly $195/month $295/month
Pre-loaded ISO 13485:2016 & 21 CFR 820 documentation:
Quality Manual, 39 Procedures, and Audit Checklist (forms are embedded in the software).
$490 (one-time-payment) 
 
ISO 13485 & 21 CFR 820 Base Software with 3 Modules
Base software with 3 modules: Document Library, Forms & Records, Document Control
Billing Cycle Standard
Edition
Professional
Edition
ISO 13485 & 21 CFR 820 IMSXpress base software with Document Library and Document Control modules. Inc. 3 Full users and cloud database hosting.   Annual $80/month $120/month
  Monthly $100/month $150/month
Pre-loaded ISO 13485:2016 & 21 CFR 820 documentation:
Quality Manual, 39 Procedures, and Audit Checklist (forms are embedded in software).
$490 (one-time-payment)
 
ISO 13485 & 21 CFR 820 Add-On Modules (requires Base Software)
Requires base software with Document Library and Document Control modules
Billing Cycle 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)
  Annual $28/month $40/month
  Monthly $33/month $50/month
 Change Control module:
 Use for document, engineering, and process
 changes. Fully integrated with Doc Control module.
  Annual $17/month $25/month
  Monthly $21/month $30/month
 Risk Management module:
 Use for ISO 14971 device risk management
 and to manage QMS related risks (refer to new
 ISO 13485:2016 risk related requirements).
  Annual $28/month $40/month
  Monthly $33/month $50/month
Forms/Records module:
 Use for making fillable PDF form templates, and for filling the forms with data and creating records.
  Annual $17/month $25/month
  Monthly $21/month $30/month
 CAPA module:
 Use for recording and processing CAPAs.
 Integrated with Complaints and NC Products modules.
  Annual $12/month $17/month
  Monthly $14/month $20/month
 Complaint module:
 Use for recording and processing complaints.
 Integrated with CAPAs and NC Products modules.
  Annual $12/month $17/month
  Monthly $14/month $20/month
 Products module:
 For each product (device) track changes, CPAs, complaints, nonconformities, risk management, audit findings, and supplier nonconformities.
  Annual $12/month $17/month
  Monthly $14/month $20/month
 Nonconforming (NC) Product module:
 Use for recording and processing NC products.
 Integrated with Complaints and CAPAs modules.
  Annual $12/month $17/month
  Monthly $14/month $20/month
 Internal Audits module:
 Use for planning and monitoring internal audits
 and for processing audit findings.
  Annual $12/month $17/month
  Monthly $14/month $20/month
 Management Reviews module:
 Use for recording management reviews
 (also suitable for design reviews).
  Annual $12/month $17/month
  Monthly $14/month $20/month
 Supplier Control module:
 Use for approving suppliers and for
 maintaining their quality performance records.
  Annual $12/month $17/month
  Monthly $14/month $20/month
 Measuring Equipment module:
 Use for managing measuring equipment
 calibration records.
  Annual $12/month $17/month
  Monthly $14/month $20/month
 Preventive Maintenance module:
 Use for scheduling and administrating maintenance,
 and for managing spare parts inventory.
  Annual $17/month $25/month
  Monthly $21/month $30/month
SaaS Subscription Additional Users
Full Users, Basic Users and Offline Trainees
Billing Cycle Standard
Edition
Professional
Edition
Additional Full User accounts
(You can change quantity in the shopping cart)
  Annual $21/month $29/month
  Monthly $25/month $36/month
Additional Full Users - 5 user licenses packet
(10% discount)
  Annual $95/month $135/month
  Monthly $113/month $162/month
Additional Full Users - 10 user licenses packet 
(15% discount)
  Annual $179/month $255/month
  Monthly $214/month $306/month
Additional Full Users - 20 user licenses packet 
(20% discount)
  Annual $336/month $480/month
  Monthly $403/month $576/month
Additional Basic User accounts
(You can change quantity in the shopping cart)
  Annual $13/month $15/month
  Monthly $16/month $18/month
Additional Basic Users - 5 user licenses packet
(10% discount)
  Annual $60/month $81/month
  Monthly $75/month $99/month
Additional Basic Users - 10 user licenses packet
(15% discount)
  Annual $115/month $153/month
  Monthly $142/month $189/month
Additional Basic Users - 20 user licenses packet
(20% discount)
  Annual $204/month $272/month
  Monthly $252/month $336/month
Additional Offline Trainee
(You can change quantity in the shopping cart)
  Annual $4/month $5/month
  Monthly $5/month $6/month
Additional Offline Trainee - 10 licenses packet
(10% discount)
  Annual $34/month $45/month
  Monthly $41/month $54/month
Additional Offline Trainee - 20 licenses packet
(10% discount)
  Annual $60/month $80/month
  Monthly $72/month $96/month
Additional Offline Trainee - 100 licenses packet
(10% discount)
  Annual $188/month $250/month
  Monthly $225/month $300/month
Remote Desktop Access For Mac Computers Only
To run the software on a Mac computer you need to install Windows OS or Windows emulator on the Mac, or purchase from us the Remote Desktop Access service.
Remote Desktop Access
(For Mac Computers)
  Annual $15/month
  Monthly $18/month
If you require a quote, please contact us by phone +1 626 796 9000 or email cs@imsxp.com
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, Basic and Offline Trainee accounts are explained in the User Licenses and Accounts page.
The template documentation package is billed only once on initial purchase. It is not refundable.