An ISO 13485:2016 supported quality management system is applicable to the medical device industry and follows the ISO 9001 process model of Plan, Do, Check, Act designed for regulatory compliance. It is more prescriptive, requiring a demanding Quality Management Systems and documentation.
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The medical devices industry must focus on the quality and safety of the products due to its implications for patient health and safety. Having an ISO 13485 certified QMS software system has many benefits. Some of them are:
‘Medical Device’ is a terminology used for a wide variety of ‘devices’ associated with the treatment or therapy of a…
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ComplianceQuest Modern Cloud Enterprise Quality Management System (EQMS) supports the latest edition of ISO 13485 by automating the entire QMS requirements while maintaining full traceability. ComplianceQuest provides solutions that help top management with the oversight of their quality management system embedded in their organization and maintenance of its effectiveness by:
Some of CQ’s ISO 13485 software system features are listed below:
Risk assessments to determine the actions necessary for mitigation or to initiate changes to QMS processes
Dashboards and reports to provide insight into overall performance and efficacy
CQ Complaints Management solution to capture customer inquiries, cases, product quality issues, and adverse events
CQ Change Control and management software to capture all the information for any change to product, services, or the quality management system, including the relevant tasks to meet quality requirements and objectives
CQ Equipment Management software allows an organization to manage the schedule for equipment maintenance. It will enable the capture of equipment calibration output to determine their status and overall lifecycle performance
CQ Audit Management software allows an organization to perform internal safety audits for the work environment and contamination control
CQ Non-conformance solution enables organizations to streamline recording and manage all quality events from single or multiple sites in one centralized system
ComplianceQuest provides reports and dashboards to fully monitor quality processes across the organization based on key company metrics/goals, regulatory requirements, and customer satisfaction
All documents associated with production and service provisioning can be controlled and maintained in the CQ Document Management solution
ComplianceQuest provides an organization with a complete set of solutions for managing Suppliers, including supplier on-boarding, supplier audit, approved supplier list, receiving inspections, supplier corrective action (SCAR), supplier portal for document and data exchange, and supplier ratings/scorecard for monitoring a supplier’s quality performance
ComplianceQuest provides training management for job function and compliance through classroom sessions, online/SCORM content, or documents
CAPA allows the organization to identify and track correcting, preventing, or reducing issues while implementing continuous improvement and effectiveness checks
ComplianceQuest offers cloud-based Quality Management Software (QMS) to plan, monitor, and improve its overall quality management. ComplianceQuest helps organize a company’s ISO 13485:2016 needs while efficiently helping auditors and notified bodies to find what they need quickly and effortlessly. The robust EQMS platform helps organizations meet their ISO 13485:2016 requirement in various criteria, including:
Customer Success
ISO 13485 software is useful to organizations focusing on the design, production, installation, and servicing of medical devices and their related services. By definition, a medical device is any product, such as a machine, instrument, implant, or in-vitro reagent, that is manufactured for its use in the diagnosis, prevention, or treatment of diseases and other medical conditions. The standard is also applicable to certification bodies that help these organizations with their auditing processes.
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.
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Helps to reduce manufacturing costs
Improves productivity and efficiency
Enhances customer satisfaction
Increase profitability
Provides competitive advantages
Protects organization’s reputation and builds on relationships
The ISO 13485 software system helps medical device manufacturers with:
Ensures compliance with regulatory requirements and international standards for medical devices.
Enhances patient safety by minimizing risks associated with medical devices.
Promotes consistent and reliable product quality, traceability, and documentation.
Establishes effective processes, controls, and documentation throughout the product lifecycle.
Facilitates continuous improvement, risk management, and regulatory compliance.
Safeguards medical devices' safety, efficacy, and quality to benefit patients and healthcare providers.
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