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ISO 13485:2016 & 21 CFR 820 Complete Starter Package
4-product bundle with all you need to implement
ISO 13485 and/or FDA QSR
Starter Package Quick Tour  
QMS Software Quick Tour  
Item 1 - Document Control and QMS Management Software
13 Modules:
  • Document Control
  • Document Distribution (Library)
  • Complaints
  • Corrective/Preventive Action (CAPA)
  • Internal Audit
  • Nonconforming Product
  • Risk Management
  • Management Review
  • Automated Training
  • Supplier Control
  • Preventive Maintenance
  • Measuring Equipment
  • Change Control
Electronic quality management system (QMS) software compliant
with 21 CFR Part 11 (Electronic Records and Electronic Signatures) 
Formally validated to FDA, ISO and IEC requirements
>>More Information
Item 2 - ISO 13485/FDA QSR Template Documentation
  • Quality Manual
  • 39 Operational Procedures
  • 43 Forms
  • All template documents are pre-loaded into the software (item 1)
>>More Information
Item 3 - Internal Audit and Gap Analysis Checklist
  • 30-page MS Word checklist with integrated internal auditor guide
  • Covers both ISO 13485:2016 and 21 CFR Part 820
>>More Information
Item 4 - Employee Training - Self-study Course for Personnel
  • 24-page training booklet
  • Multiple choice test
  • Certificate of completion
>>More Information
 
Purchase Options
  • Subscribe: Software as a service (SaaS) with database cloud hosting
  • Purchase to own: install software and database on your own server
>>  Purchase Starter Package
Three editions
  • Light
  • Standard
  • Professional
>> Editions and Feature Chart
Related Information
>> Part 11 Certificate >> Validation Certificate >> Editions and Feature Chart >> Installation Options
Download Free Trial
Install free trial software on your computer and test it for 30 days.
>>  Download Free Trial
Sign up for a Web Presentation
Sign up for a live web presentation of IMSXpress Document Control and QMS Management Software with Complete Starter Package. The web presentation takes 30 to 45 minutes.
>>  Sign up for a Web Presentation