Medical Device Document Control Software

Streamline your document control activities and ensure compliance with the FDA 21 CFR Part 820 and ISO 13485 Quality Standards.

Change Request Document in SimplerQMS


What’s in SimplerQMS Medical Device Document Control Software?

SimplerQMS provides a cloud-based document control software for the medical device industry which integrates with the full quality management solution suite. It helps the manufacturers of medical devices create and manage documents, control changes, and approve documents electronically.

Change Request Document in SimplerQMS

Click to Enlarge Image

Streamline Document Control Processes in Your Organization

Manual document management processes are often inefficient and leave room for human error. SimplerQMS provides automated workflows for document creation, review, approval, distribution, reminders, escalation, and email notifications.

Easily create documents using our best-practice forms and templates (or use your own). Work in a familiar Microsoft Office interface with full editing capabilities and save documents in the SimplerQMS cloud with one click.

Centralized, cloud-based file storage ensures that documents are securely stored and can be accessed by authorized personnel from anywhere, at any time.

Ensure Regulatory Compliance and 100% Audit Readiness

SimplerQMS is designed to help medical device companies meet the document control requirements of FDA’s 21 CFR Part 820 and Part 11, ISO 13485, and cGMP.

Automatic version control and revision control help you ensure that only the most current and approved documents are accessible.

FDA 21 Part 11 compliant electronic signatures, time-stamped audit trails of all document changes, and a centralized repository help you assure compliance and maintain 100% audit readiness at all times.

Change Request Audit Trail in SimplerQMS

Click to Enlarge Image

Automated CAPA Trending Report in SimplerQMS

Click to Enlarge Image

Integrate all Quality Processes and Gain Visibility

Disconnected tools and siloed quality data make it difficult to get a holistic view of your medical device quality management system. SimplerQMS document management system interconnects with all quality processes, providing medical device manufacturers with a complete overview of their QMS.

Ensure that your documents are filed in the right archives, link them to current and future R&D projects, and organize them for regulatory submissions for FDA approvals or CE marking.

From customer complaints to NCs and CAPAs, from suppliers to audits, get a complete overview of your quality system in one place. Use customizable dashboards and reports to track progress, identify gaps and drive continuous improvement.

Save Time, and Money by Choosing a Fully Validating Software

SimplerQMS provides a fully validated software solution according to FDA 21 CFR Part 11, ISO13485:2016, and GxP guidelines. We conduct continuous re-validation of the system, including IQ, OQ, and PQ validation tests, and provide extensive validation evidence for use during audits and inspections.

This drastically lowers the software deployment costs and time resources when compared to legacy document control systems and QMS software solutions, allowing you to focus on more value-adding processes.

Validation Applicability Matrix

Click to Enlarge Image

All-in-One eQMS for Medical Device Organizations

Training Management

Save time and ensure that employees are always up-to-date on the latest quality procedures.


Automate the identification, registration, evaluation, analysis, and management of nonconformances.

CAPA Management

Interconnect your CAPA processes with the entire product life cycle, to identify and address problems more effectively.

Audit Management

Automate audit-related activities, and make it simpler and easier for your medical device organization to pass audits with flying colors.

Change Control Management

See, understand, and manage every document change appropriately within a fully traceable platform that connects all processes.

Supplier Management

Automate and streamline your supplier management processes, from supplier selection to monitoring.

Frequently Asked Questions

What is Medical Device Document Control Software?

Medical device document control software is designed to streamline document management processes and ensure compliance with regulatory requirements such as the FDA’s 21 CFR Part 820 and Part 11, ISO 13485, and cGMP.

The software automates document creation, review, approval, and distribution processes. It includes features such as version and revision control, electronic signatures, full audit trails, and a centralized document repository.

This allows companies to manage their documents more efficiently, gain better visibility into the status of their quality management system (QMS), and save time and money on manual document control processes and compliance activities.

What Makes SimplerQMS Medical Device Document Control Tools Popular?

Popular SimplerQMS document control system software features include the following:

  • Integration with familiar Microsoft Office tools such as Word, Excel, and PowerPoint.
  • FDA 21 CFR Part 11 compliant electronic signatures.
  • SimplerQMS comes pre-validated and ensures continuous re-validation.
  • Centralized, cloud-based repository, and quick access to documents – with a few clicks.
  • Document versions and revisions.
  • Time-stamped audit trail of document change history.

Is SimplerQMS Document Control Software 21 CFR Part 11 Compliant?

SimplerQMS is a 21 CFR Part 11 compliant software system, designed to help medical device manufacturers and other life science companies comply with the Electronic Signature and Digital Record practices set forth by the FDA’s 21 CFR Part 11.

How Much Does Medical Device Document Control Software Cost?

SimplerQMS document control solution is part of an all-in-one QMS solution suite, which includes all system modules (training, NCs. CAPAs, suppliers, etc.), implementation, training, ongoing support, validation, hosting, and more.

This means that everything is included in the price you pay and there are no other costs associated with subscribing to SimplerQMS.

We recommend that you request a demo of our software to see how it can benefit your organization and request a pricing quote for your specific needs.

What Customers Achieve With SimplerQMS

“The chance of a human error in the process of filling out documents has been reduced. There are several different human errors that have been eliminated and we feel like the system helps us to catch possible human errors more easily.”

christian photo

Christian Schärfe Thomsen
Project Manager, Cortex

Ready to learn more?

To learn how your medical device organization can make the most of SimplerQMS, request a personalized demo.

SimplerQMS Demo Interface