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ISO 13485

ISO 13485 is an international management standard developed specifically for medical device manufacturers. It provides a harmonized model for creating and maintaining an effective quality management system (QMS) for the design and manufacture of medical devices. In 2016, ISO 13485 was revised to address suppliers and incorporate risk. ISO 13485:2016 explicitly requires device makers to apply a risk-based approach to all quality processes, including outsourced processes, as well as more structure to validation, verification and design transfer. ISO 13485:2003-certified companies have three years to transition to ISO 13485:2016.

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Educational Materials

Get insider information about the most relevant issues in ISO 13485 today, and how to navigate and overcome the complexities of FDA and ISO compliance.

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White Papers
  • This white paper provides a concise overview of ISO 13485 and examines how obtaining certification to the standard can open doors to untapped domestic and international business opportunities. It also explains how to avoid becoming one of the 50 percent of device companies that fail to obtain recertification due to inadequate manual processes.
  • Since the majority of medical device manufacturers must comply with both 21 CFR 820 QSR and ISO 13485 standards, it is practical to consider establishing an integrated 21 CFR 820 and ISO 13485 quality management system (QMS). This white paper delineates the intersection points of these regulatory requirements and provides valuable information about document naming and numbering strategies for enhanced compliance.
Product Data Sheets
  • This webinar is Part 2 of the ISO 13485:2016 webinar series. It addresses the universal changes in this regulation and how to implement them.
  • This webinar is Part 3 of the ISO 13485:2016 webinar series. It addresses the universal changes in this regulation and how to implement them.

Educational Materials

  • Since 2000, we have benefited from a technology-driven era in regulatory compliance. This e-book identifies 16 laws and initiatives that have helped spur such modernization. It explores how the use of technology in the past decade has helped both sides of the fence—regulated companies and regulatory agencies—in easing the pains and costs of compliance.

Product Information

Discover how MasterControl ISO 13485 can manage your quality process, all while mitigating risk, improving speed-to-market, and generating ROI.

Product Data Sheets
Product Data Sheets
Product Data Sheets
  • What do you need to know about compliance with 21 CFR 820 and ISO 13485? This informative question and answer summary explains what these standards are, who they cover, their relationship to each other, and much more.

Demos & Toolkits

Get in-depth, comprehensive resources to guide development of your ISO 13485 program.

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Interactive and Live Demonstrations
  • The MasterControl quality management system (QMS) delivers a wide range of software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management, and more based on your business needs. This overview demonstration shows how MasterControl's QMS eliminates waste, simplifies audits, and facilitates compliance with regulatory guidelines.
Product Data Sheets

How MasterControl Helps Device Makers Meet the Latest Requirements of ISO 13485

The MasterControl quality management suite is an integrated, configurable, and easy-to-use software solution especially designed to facilitate adherence to the latest ISO 13485 standard. Here's how MasterControl can help meet key requirements and at the same time increase efficiency and keep compliance costs down:

ISO 13485 Requirements

MasterControl Features to Ensure Compliance with ISO 13485

(ISO 13485 -- Clause 4)

Requires establishment of a quality management system for medical devices. A manufacturer must have quality procedures compliant to ISO 13485 that are documented, controlled, and effectively implemented and maintained.

MasterControl Documents™ helps medical device companies comply with ISO 13485 by automating routing, escalation, approval, and delivery of standard operating procedures SOPs, policies, and other documentation. MasterControl provides automatic revision control to ensure that only the current version of an SOP is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The system tracks these changes and makes them available through reports which ultimately helps in meeting these standards.

Requires written supplier agreements and risk-based control of outsourced products.

With MasterControl Supplier™, all supplier management statuses and quality information is automatically contained in a single, easy to access location. In addition to providing an easily maintainable AVL, MasterControl Supplier features a user-friendly interface for accessing all documentation and records related to each supplier.

MasterControl Risk™ provides employees from different departments with a simple and efficient method for participating in risk assessment and mitigation activities. MasterControl's risk management software offers electronic workflows and signatures for execution, review, and approval of risk activities and documentation. Personnel can leverage a risk-based approach in multiple processes including supplier qualification activities.

(ISO 13485 -- Clause 6)

A manufacturer must ensure that its personnel have the right experience, education, training, and skills. Acceptable levels of competence must be defined. Training needs must be established and assessed. A record of competence must be maintained.

Effectiveness of training must be commensurate with risk.

MasterControl Training™ helps medical device companies comply with ISO 13485 by automating the assignment and monitoring of training tasks and grading of online exams. The software allows sequencing of training courses, so after a prerequisite is completed; the next course is automatically launched. Provides group sign-off feature for verifying training of large groups of employees.

MasterControl's risk analysis software solutions include triggers to perform a risk analysis. This enables a methodology that establishes objective risk metrics. These can then be used as thresholds for decision-making.

(ISO 13485 -- Clause 8)

A manufacturer must plan how remedial processes will be used to assure conformity. It must use remedial processes to demonstrate conformance. It must establish a nonconforming products procedure; nonconformances must be corrected and documented.

MasterControl CAPA™ helps medical device manufacturers comply with 13485 by integrating the corrective and preventive action process with other quality processes. The software provides best-practice "8D" process that guides the quality team through every step of CAPA. A CAPA form can be launched directly from another form (i.e., a nonconformance report). Automatically enters relevant data into a CAPA form, reducing data entry and eliminating errors from manual transfer of information. Provides customizable reporting capabilities to help managers monitor entire quality management life cycle.

(ISO 13485 -- Clause 8)

A manufacturer must plan and perform regular internal audits.

MasterControl Audit™ helps medical device manufactures comply with ISO 13485 by automating, streamlining, and effectively managing the audit process. The audit software provides advanced tracking capability, from scheduling and planning to execution and completion. Offers best practice forms for tracking basic audit information and audit findings. Automates scheduling of all recurring audit-related activities and provides analytics and reporting capability for Increased Management Visibility.

(ISO 13485 -- Clause 8)

A manufacturer must create a procedure to gather feedback from customers and a feedback system to monitor emerging problems.

MasterControl Customer Complaints™ helps medical device manufacturers comply by streamlining the complaint-handling process and reduces the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with processing of a complaint, moving to internal investigation, and culminating with issue resolution.

(ISO 13485 -- Clause 5)

The organization shall document procedures for timely complaint handling in accordance with applicable regulatory requirements.

MasterControl Nonconformance™ is a robust solution designed to help medical device manufacturers comply with ISO 13485 by automating, managing, and streamlining the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products. The solution's best-practice form and five-step process connect all responsible personnel for effective and timely disposition of a nonconformance.

For More Information on Document Control Software Systems

For additional details about the Document Control Software Systems from MasterControl, please feel free to contact a MasterControl representative.