
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.
ISO 13485 Medical Devices and Related Assets
ComplianceQuest provides a complete suite of applications to ensure compliance to regulations like ISO 13485, a quality requirement for medical device companies.
Requirements for Medical Devices QMS – ISO 13485


CQ’s Integrated Cloud-Based ISO 13485 Software Solution

Major MedTech Company Takes Quantum Leap, Modernizes Legacy Quality Management System
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 – CAPA ⦁ 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 |
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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 |
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7.3 Design and Development | ⦁ CQ – Document Management ⦁ CQ – CAPA Management |
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7.4 Purchasing | ⦁ CQ – Supplier On-boarding ⦁ CQ – Supplier Portal ⦁ CQ – Audit Management ⦁ CQ – CAPA (SCAR) Management |
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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 |
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8.3 Control of Nonconforming Product | ⦁ CQ – Nonconformance Management ⦁ CQ – CAPA Management |
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8.4 Analysis of Data | ⦁ ComplianceQuest Suite ⦁ Dashboards ⦁ Reporting ⦁ Query |
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8.5 Improvement | ⦁ CQ – Document Management ⦁ CQ – CAPA Management |
8 Next-Gen MedTech Techniques Applied During Design and Development

Amazingly Robust, Compliant and Easy to Use
Niyati Patel, Manager-Quality Assurance
