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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 15 modules. Incl. 3 Full users and cloud database hosting.   Annual $2,500/year $3,300/year
  Monthly $250/month $330/month
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. This item is nonrefundable.
$760 (one-time-payment) 
ISO 13485:2016 & 21 CFR 820 Internal Audit Checklist (can also use for Gap Analysis). $110 (one-time-payment) 
 
SaaS Subscription Additional Users
Discounts available for 10 or more Full, Basic or Offline Trainee licenses
Billing Cycle Standard
Edition
Professional
Edition
Additional Full User account
(You can change quantity in the shopping cart)
  Annual $348/year $468/year
  Monthly $35/month $47/month
Additional Basic User account
(You can change quantity in the shopping cart)
  Annual $174/year $234/year
  Monthly $18/month $24/month
Additional Offline Trainee account
(You can change quantity in the shopping cart)
  Annual $58/year $78/year
  Monthly $6/month $8/month
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
Upgrade Add-On Modules (for existing systems)
For systems that were purchased before these new modules existed
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 $450/year $550/year
  Monthly $45/month $55/month
 Change Control module:
 Use for document, engineering, and process
 changes. Fully integrated with Doc Control module.
  Annual $450/year $550/year
  Monthly $45/month $55/month
 Risk Management module:
 Use for ISO 14971 device risk management
 and to manage QMS related risks.
  Annual $450/year $550/year
  Monthly $45/month $55/month
Forms/Records module:
Use for making fillable PDF form templates, and for filling the forms with data and creating records.
  Annual $450/year $550/year
  Monthly $45/month $55/month
 Preventive Maintenance module:
 Use for scheduling and administrating maintenance,
 and for managing spare parts inventory.
  Annual $450/year $550/year
  Monthly $45/month $55/month
 Products module:
 For each product (device) track changes, CPAs, complaints, nonconformities, risk management, audit findings, and supplier nonconformities.
  Annual $450/year $550/year
  Monthly $45/month $55/month
If you require a quote, please contact us by phone +1 626 796 9000 or email cs@imsxp.com
For the Purchase-To-Own option go to the PTO store.
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 and the internal audit checklist are billed only once on initial purchase. They are not refundable.