ISO Standards  >  ISO 13485 Medical Devices

ISO 13485 Medical Devices

iso 13485 medical devices
iso 13485 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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Requirements for Medical Devices QMS – ISO 13485

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 13485 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

Major MedTech Company Takes Quantum Leap, Modernizes Legacy Quality Management System

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Amazingly Robust, Compliant and Easy to Use

I brought in ComplianceQuest to my company, to fill a need in electronic document management and control. But we did not realize how much we needed it for our processes and procedures specifically. It is so adaptive and configurable that it meets our needs in almost every way. We started our implementation of the Document Control module with ComplianceQuest in Q4 2017. Our experience has been overall very positive throughout selection to implementation.

Niyati Patel,
Manager-Quality Assurance


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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