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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.

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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

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.

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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.

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Change Request Audit Trail in SimplerQMS
Automated CAPA Trending Report in SimplerQMS

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.

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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.

Learn more about validation

Validation Applicability Matrix

All-in-One eQMS for Medical Device Organizations

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Document Control

Keep your documents audit-ready while managing a high volume of data accurately.

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Training Management

Develop employee competence while maintaining compliance. Streamline the training process with learning rules and training groups, automate task assignments, reminders, and more.

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Change Management

Streamline change control processes from change request submission to final approval and successful implementation.

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Deviation Management

Enhance investigation, documentation, and resolution of deviations through a streamlined deviation management process.

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CAPA Management

Enhance your corrective and preventive actions to enforce continuous improvement and resolve issues as they arise.

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Complaint Management

Streamline your complaint management workflow and turn complaints into product improvement opportunities and increase customer satisfaction.

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Audit Management

Reduce the time and effort needed to pass audits successfully by streamlining audit-related activities.

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Risk Management

Consolidate and organize risk management documentation throughout all quality processes.

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Equipment Management

Simplify the equipment registration, calibration, and maintenance tasks with straightforward workflows.

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Supplier Management

Manage your supplier quality management processes across your supply chains, from initial qualification and selection through ongoing monitoring and performance measurement.

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Frequently Asked Questions

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.

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.

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.

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

Utilize Proven Technology

SimplerQMS is built on Microsoft & M-Files Technology which serves over 5,000 customers worldwide.

Pass audit more easily

Access needed documentation and present it to the auditor with a couple of clicks from anywhere in the world.

Gain high level of traceability

Gain cross-functional visibility and trace back to the root cause of each nonconformance.

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.

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Christian Schärfe Thomsen

Project Manager, Cortex

What Our Customers Say

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Star review

“Spending most of my day using SimplerQMS, I would say I am very pleased with the ease of use.”

Dorthe W.

QA/RA Manager, Cortex Technology

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Star review

“SimplerQMS gave us excellent pricing, customer support for understanding how to use their system and set up our QMS, and is easy to use.”

Subba S.

Chief Technology Officer, CollaMedix

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Star review

“Easy to work with. Intuitive. Rather easy to setup. Very good customer support. Good quality to price ratio.”

Jean Claude M.

Head of Hardware and Software Development, hemotune

See SimplerQMS in Action

To see SimplerQMS in action and learn how you can make the most of it, request a personalized demo presentation.

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