Jump to Section

Introduction

Key Features of ISO 13485 Software 

ISO 13485 Software Validation

How Much Does ISO 13485 Software Cost?

Conclusion

ISO 13485 Software Guidelines

February 21, 2024

Today’s medical device regulatory environment puts the onus for quality mostly on the shoulders of medical device manufacturers. Thankfully, it has also given them a guide to meeting quality requirements internationally: ISO 13485. But achieving and maintaining compliance with ISO 13485 is a complex endeavor.

ISO 13485 software offers a streamlined solution to navigate the intricate requirements of the standard, as well as FDA regulations. In this article, we delve into the significance of ISO 13485 software, its features and benefits, and ways manufacturers and their suppliers can best uphold the highest measure of quality in the medical device industry.

What is ISO 13485 software?

ISO 13485 is the international standard outlining the quality management criteria that medical device manufacturers must undertake to meet regulatory requirements. Developed by the International Organization for Standardization (ISO), compliance with ISO 13485 demonstrates an organization's commitment to ensuring the consistent safety, effectiveness and compliance of its medical devices.

ISO 13485 software automates the tasks medical device companies must undertake to comply with ISO 13485 quality standards, centralizing and streamlining processes. ISO 13485 software, generally called a Quality Management System (QMS), can be used at every stage of the med device lifecycle, from design and development to manufacturing and distribution.

Key features of ISO 13485 software

ISO 13485 software provides a comprehensive solution to address the challenges of compliance and quality management in the medical device industry. It provides features to address each of ISO 13485:2016 mandatory requirements, which center around six important sections:

• General and documentation requirements
• Management responsibility
• Resource management
• Product realization plan
• Communication at every stage
• Measurement, analysis and improvement

ISO 13485 Document Control Software

ISO 13485 document control software controls documents and records, centralizing documentation in one place and providing FDA 21 CFR Part 11-compliant electronic signature approvals. ISO 13485 software shapes and manages document control compliance, including the following:

• Centralizes and organizes documents so they are accessible anytime, from anywhere
• Establishes version control to ensure the latest information is used
• Provides full transparency and traceability with an electronic timeline of document changes
• Utilizes electronic review and approval with electronic signature compliance
• Controls access
• Triggers training related to document changes

ISO 13485 software also can provide a way to automate Design History Files (DHFs), as required under the standard. A DHF contains all of the documentation created during the product design and development stages of your product. ISO 13485 document control software easily stores those documents in one place, simplifying compliance and giving you access to records anytime and anywhere. Similarly, Device History Records (DHRs) and Device Master Records (DMRs), can be centralized and maintained with integration to QT9’s ERP, providing an electronic timeline of all changes for full trackability and traceability.

Management Responsibility

Medical device company management has broad-ranging responsibilities under ISO 13485, from creating quality objectives to providing the appropriate resources and environment, to establishing a culture of continuous quality. As a QMS, ISO 13485 software provides the path for both management and staff to meet their quality goals.

Resource Management

Automated employee training supports regulatory compliance and promotes a culture of quality by connecting document and system changes to employee training events. With most ISO 13485 software, training can be created and assigned based on job duties. Employees get email prompts and reminders to complete training, and management gets a real-time view of employee training progress. 

Equipment and facilities maintenance requirements can also be automated using ISO 13485 software. Instrument calibration applications can generate maintenance schedules, reminders and reports to produce a verifiable audit trail, confirming equipment has been properly maintained.

Product Realization

The components of the product realization section of ISO 13485 touch every stage of the medical device lifecycle. ISO 13485 software helps organize and structure activities during each stage, including design, inspection and corrective actions.

Risk management applications allow you to harness data to identify and monitor potential risks, automating associated tasks such as creating, evaluating and reporting on risk assessments. Risk assessments are integrated from a variety of additional integrated applications, such as corrective actions and engineering change requests (ECRs).

ISO 13485 software can automate supplier management, such as supplier evaluations, data mining and trending, and communication, making it easier to keep track of supplier activities and products.

Measurement, Analysis and Improvement

Section 8 of ISO 13485 calls for monitoring med device customer requirements via feedback, complaint handling, regular audits and appropriate internal controls. ISO 13485 software automatically manages documentation and reports with full traceability, including customer feedback tools that can integrate with the rest of the quality management system.

Automated customer feedback lets you digitally track customer complaints and other communication so you can chart and trend findings and link to CAPA or risk management. Corrective and preventive action (CAPA) applications provide tools to manage all CAPA processes, from root cause analysis to approvals and verification of effectiveness.

Benefits of ISO 13485 software 

ISO 13485 software offers a comprehensive solution to address the challenges of compliance and quality management, offering a central repository for device information, creating efficiencies and providing assurance that manufacturers are meeting regulatory requirements. Primary benefits include:

• Integration of quality processes
• Automated document control and regulatory compliance
• Audit preparedness
• Traceability and version control
• Streamlined risk management planning and control
• Real-time monitoring and reporting

ISO 13485 and FDA Regulations

In January 2024, the FDA published a final rule amending 21 CFR Part 820, the FDA’s quality system regulation. The change will officially bring FDA med device quality requirements in line with ISO 13485. The revised part 820 is referred to as the Quality Management System Regulation (QMSR) and goes into effect on February 2, 2026.

ISO 13485 remains a voluntary standard, but medical device manufacturers can rest easier in the knowledge that adherence to the standard will be tantamount to FDA compliance. With the new rule, the FDA brings its requirements more in line with international standards.