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ISO 13485 Quality Management System for Medical Devices

The ISO 9001 Group’s ISO 13485 quality management system consultants are experts that understand the steps to achieve ISO 13485 certification or compliance for medical devices. We can help your organization design, develop and implement an ISO 13485:2016 certification ready management system from the ground up. We have perfected our proven 4 step process.  Our 4 step process has resulted in a 100% Client Certification Rate for our clients, which means that when our clients follow our process and consulting, they obtain ISO 13485 certification 100% of the time.


Contact us today to find out more about how The ISO 9001 Group can assist your organization achieve its ISO 13485 certification goals.

Benefits of ISO 13485

• Win more bids where certification is a requirement or a competitive advantage

• Provides the foundation for obtaining CE marking, which is required to gain access to the European market

• Meet customers’ requirement for certification

• Improved structure, processes and procedures internally

• Better internal controls, which will improve operations and reduce risks

• Achieve ISO 13485 certification

ISO 13485 Overview

• Medical Device File

• Management Responsibility

• Customer Focus

• Responsibility, Authority and Communication

• Management Review

• Resource Management

• Human Resources

• Infrastructure

• Contamination Control

• Planning of Product Realization

• Design and Development

• Cleanliness of Product

• Installation Activities

• Servicing Activities

• Particular Requirements for Sterile Medical Devices

• Particular Requirements for Validation of Processes for Sterilization and Sterile Barrier Systems

• Measurement, Analysis and Improvement

• Complaint Handling

• Internal Auditing

• Control of Nonconforming Product

• Corrective and Preventive Action


Visit International Organization of Standardization‘s website to learn more about ISO 13485.

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