ISO Standards  >  ISO 13485 Medical Devices

ISO 13485 Medical Devices

iso for medical devices
iso for medical devices

What is ISO 13485 for Medical Devices?

Today’s competitive business environment has placed tremendous pressure on medical devices manufacturing companies to lower operating costs, address complex product design, outsource development and seek global expansion plans. Beyond this pressure there is major opportunity for companies to build a competitive advantage through an integrated risk and compliance management approach that ensures all features are working together effectively, enabling superior visibility into the value chain.

Medical Devices manufacturing processes and supply chain management that were once easy to handle are now much more complex. What used to be controlled and contained within the manufacturing plant is now monitored, run and maintained globally. Given this situation, building an effective risk and quality compliance system that conforms to management standards like ISO 13485 and ISO 9000 among others, is imperative for companies that want to work efficiently and succeed over smarter customers.

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ISO for Medical Devices Requirements

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective is to facilitate ISO 13485 medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9000 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems follows all the requirements of ISO 9001. All requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size of the organization.

iso for medical devices requirements
iso 13485 medical devices software

CQ’s Integrated Cloud-Based ISO 13485 Software Solution

ComplianceQuest – Enterprise Compliance and Quality Management Software (EQMS) is an integrated cloud based ISO 13485 software solution that goes above and beyond the requirements for ISO 13845 while automating your entire quality management system requirements. CQ significantly reduces the effort involved in maintaining your ISO 13485 Quality System by building the required processes to be automated while maintaining full traceability. Imagine, the time and money your company can save with an intuitive web based system, which will replace all the hard copies, and those random word and excel files. CQ was designed from the ground-up to be not only extremely user friendly at all levels but provide for a very powerful platform to scale from a small company to a large global enterprise. CQ helps you organize your company’s ISO requirements improving productivity while easily helping the auditors to find what they need quickly and effortlessly.

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ComplianceQuest – ISO 13485 Compliance Chart

Section ComplianceQuest Solution(s)
4. General Quality Management 4.1 – General Requirements ComplianceQuest – Suite
4.2 – Document Control CQ – Document Control
5. Management Responsibility 5.1 Management Commitment ComplianceQuest Suite/ CQ – Audit Management
5.2 Customer Focus ⦁ CQ – Portal
⦁ CQ – Customer Complaints
⦁ CQ – Chatter
⦁ CQ – Collaboration
⦁ CQ – Dashboards/Reporting
5.3 Quality Policy ⦁ CQ – Document Management,
⦁ CQ- Training Management
5.4 Planning Document Management
5.5 Responsibility, Authority and Communication ComplianceQuest Suite
5.6 Management Review ⦁ ComplianceQuest Suite
⦁ CQ – Audit Management
6. Resource Management 6.1 Provision of Resources Not Applicable
6.2 Human Resources CQ – Training Management
6.3 Infrastructure ⦁ CQ – Calibration Management
⦁ CQ – Audit Management
⦁ CQ – CAPA Management
6.4 Work Environment and Contamination Control Not Applicable
7. Product Realization 7.1 Planning of Product Realization Not Applicable
7.2 Customer-Related Processes ⦁ CQ – Customer Complaints Management
⦁ CQ – CAPA Management
7.3 Design and Development ⦁ CQ – Document Management
⦁ CQ – CAPA Management
7.4 Purchasing ⦁ CQ – Supplier On-boarding
⦁ CQ – Supplier Portal
⦁ CQ – Audit Management
⦁ CQ – CAPA (SCAR) Management
7.5 Production and Service Provision Not Applicable
7.6 Control of Monitoring and Measuring Equipment CQ – Calibration Management
8. Measurement, Analysis and Improvement 8.1 General ComplianceQuest Suite
8.2 Monitoring and Measurement ⦁ CQ – Customer Complaints Management
⦁ CQ – Audit Management
⦁ CQ – CAPA Management
8.3 Control of Nonconforming Product ⦁ CQ – Nonconformance Management
⦁ CQ – CAPA Management
8.4 Analysis of Data ⦁ ComplianceQuest Suite
⦁ Dashboards
⦁ Reporting
⦁ Query
8.5 Improvement ⦁ CQ – Document Management
⦁ CQ – CAPA Management

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Customer Success

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ISO for medical devices overview

International Organization for Standardization (ISO) standards play a crucial role in regulating the quality and safety of medical devices globally. These ISO standards are implemented and followed to ensure that medical devices are designed, manufactured, and distributed with a strong emphasis on quality, safety, and regulatory compliance, ultimately benefiting patients and healthcare providers. ISO for medical devices provide a framework for manufacturers to ensure their devices meet specific requirements, adhere to regulations, and prioritize patient safety.

ISO Standards for Medical Devices

ISO for medical devices
  • ISO 13485: Medical Devices - Quality Management Systems: ISO 13485 outlines the requirements for a comprehensive quality management system specific to medical devices. It focuses on processes such as design, production, risk management, and post-market surveillance, ensuring that manufacturers maintain high-quality standards and regulatory compliance.
  • ISO 14971: Medical Devices - Application of Risk Management to Medical Devices: ISO 14971 provides guidelines for identifying, evaluating, and mitigating risks associated with medical devices throughout their lifecycle. This standard emphasizes risk analysis and management to enhance patient safety.
  • ISO 9001: Quality Management Systems: While not exclusive to medical devices, ISO 9001 can be applicable. It provides a broader perspective on quality management principles and can be integrated with ISO 13485 for a more comprehensive quality system.
  • ISO 10993: Biological Evaluation of Medical Devices: ISO 10993 offers guidance for assessing the biological safety of medical devices. It outlines procedures for testing and evaluating the potential harm caused by the interaction between devices and the human body.
  • ISO 11607: Packaging for Terminally Sterilized Medical Devices: This standard addresses packaging requirements for terminally sterilized medical devices. It ensures that packaging maintains product sterility and integrity throughout the product's shelf life.

All the QMS processes in one software, excellent choice

We have implemented CQ in a new medical device start up. The set up and implementation went very smooth and the support from the provider has been outstanding. The system fully supports compliance with ISO 13485.

Some of the reasons why I would recommend the software are: – 100% cloud-based – Allow almost paperless Quality Management System – Excellent customer support – Simple set up and implementation – User friendly – Efficiency and security – Accessible cost for small companies.

Laura Granados,
QMS Systems Development Consultant

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ComplianceQuest provides a complete suite of applications to ensure compliance with regulations like ISO 13485, a quality requirement for medical device companies

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