ISO 13485 Software

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Paradigm 3: ISO 13485 Document Control Software

Paradigm 3 compliance and document control software for medical device manufacturers provides complete confidence in your ability to manage your ISO 13485 and FDA’s 21 CFR Part 11 electronic signature requirements. With Paradigm 3 ISO 13485 software managing your system no longer has to be a daunting task, numerous tools assist you in meeting and managing those requirements.

Document Control Software for Medical Devices

Targeted action items are delivered via email ensuring such tasks as, document control, calibration, training  and CAPA are understood and completed on time providing transparent validation of ISO 13485 system.

ISO 13485 Software

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Document Control

Controls all aspects of document creation, review, approval and release. Our targeted action items ensure a seamless work flow through the various phases of a document life cycle including notification of scheduled reviews and real time revision logs Our software will enable you to meet all the requirements of CFR 21 Part 11 including IQ and OQ scripts performed at installation.

Nonconformance/ CAPA /Customer Complaints

Our improvement generator module provides highly flexible processing and reporting on all requirements where an investigative workflow is required. Ensuring various steps are carried out and appropriate personnel are informed in a timely manner. Paradigm 3 not only informs persons of required actions it also allows instant access to status of individual or all outstanding issues.


Manages and tracks required education and training. Our exclusive search function allows you to search aspects of training such as who is competent to perform a certain task to what training is due next month. Action items notify applicable personnel indicating clearly what training is required, where it will be held and when. Keeping your whole training matrix in control and proactive.

Risk Management

The Paradigm 3 Risk Management methodology provides a solution for measuring and assessing risk by allowing calculated fields with association formulas to be placed within any record in the Resources Cabinet or Improvement Generator. This outstanding capability allows companies to assess risk on an incident-by-incident basis, whether it is quality, safety, environmental, or general business.

Internal Audit Management

We provides control, notification, and tracking over all facets of audit management. Our software features reminders of dates for review. Tracking of corrective actions assigned for critical issue identified, instant notifications are sent to all designated parties through all investigation and resolution phases.

Approved Vendors

The Paradigm 3 Approved Vendors database provides an extensive solution for monitoring and approving your vendors’ performance. In addition to keeping records of vendor status, this dynamic tool notifies you of scheduled reviews and score vendors directly within the database record.

Calibration Maintenance Management

Fully flexible forms to ensure the system is compatible with all types of equipment and instrument calibration or maintenance notifications. Calibrations are made easy with automatic notifications that can be scheduled for distribution according to each piece of equipment and their associated calibration/maintenance dates. auditors.

Flexible form design

Complete flexibility to design forms for collecting test results data in our Records Module. These forms enables custom searching and analysis of results found. The system also allows results to be exported to required forms with appropriate logos to send to customers or vendors as required These forms can be used for any purpose and can be integrated into legacy software.