Quality  >  Medical Device Quality Management System

Medical Device QMS, Medical Software

The highly regulated medical device industry must focus on quality at every production stage. A quality management system allows medical device manufacturers to handle all quality-related requirements with a single system.

medical device qms software
medical device qms software

QMS Medical Device Software

Implementing a Quality Management System (QMS) in the medical device industry involves defining processes, procedures, and standards to ensure product safety and efficacy. QMS medical device software includes documentation control, risk management, regulatory compliance, and continuous improvement. Organizations using Quality Management System (QMS) Medical Software can remain with ISO standards including ISO 9001:2015, ISO 14000 series, ISO 13485, ISO 19011, and ISO/TS 16949. For companies in the medical devices industry, compliance with ISO 13485 is critical to meet customer and other applicable regulatory requirements. Read on to understand the requirements of ISO 13485 and how to implement them in the organization with CQ’s Enterprise Quality Management System (EQMS).

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Integrating Quality Management Software for Medical Devices

The life sciences industry is poised for a remarkable transformation where metrics-driven business processes and regulatory compliance (such as FDA 21 CFR Part 11 and FDA Software Validation) are dominant factors for success. To sustain and flourish in the changing environment, companies have to focus more than ever before on defining, monitoring and acting on the various parameters, including managing operational risks, ensuring regulatory compliance, making quality a high priority issue, and standardizing processes across both internal and external value chain. With a focus on risk management, device manufacturers in the life science industry must realign their business and quality objectives to meet the norm set by ISO 13485:2016 using quality management software. To do so, manufacturers must invest in quality management system for medical devices. The current standard on Quality Management Software emphasizes integrating internal processes to minimize risk within the organization. This Quality Management Software integration includes:

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Product planning

capa for medical device qms software

Corrective Actions and Preventive Actions (CAPA)

verification for quality management system medical device

Verification, validation, and revalidation

medical device quality management system software for monitoring

Monitoring, testing, and traceability

medical device qms to manage risk

Risk management documentation in product realization

QMS Medical Device Software Regulations

The pharmaceutical, life sciences, and healthcare industries are highly regulated due to their direct impact on customer health and safety. A Quality Management System designed specifically for these industries should address the complex product development lifecycle of these industries. A Quality Management System’s use in the organization is to ensure compliance with FDA and other ISO standards, specifically ISO 13485. Quality Management System helps improve product quality and safety, eliminate manual quality processes, reduce overall costs, standardize processes and documentation, and enhance operational efficiency.

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How Next Generation EQMS Equips Medical Device Companies to Handle FDA’s New Approach to Quality Regulations

The Importance of Medical Device Quality Management Software (QMS)

While the main objective of quality management software is to ensure compliance with regulations and standards, it also has other growing importance. The Quality Management Software helps medical device manufacturers with:

  • Enterprise-wide data visibility of both quality and safety parameters

  • Seamless workflows and business processes

  • Easy setup for multiple standards like ISO 9001, ISO 45001, OHSAS 18001, ISO 9000:2008

  • Predictive insights for quality; proactive approach to safety

  • Aligning people and processes

  • Reducing the cost due to inefficient safety or quality process

  • Better manage risk across two misaligned systems

  • Enterprise-wide data visibility of both quality and safety parameters

  • Seamless workflows and business processes

  • Easy setup for multiple standards like ISO 9001, ISO 45001, OHSAS 18001, ISO 9000:2008

  • Predictive insights for quality; proactive approach to safety

  • Aligning people and processes

  • Reducing the cost due to inefficient safety or quality process

  • Better manage risk across two misaligned systems

Essentials of a Quality Management System (QMS) for Medical Devices

A robust Quality Management System for medical devices is vital to ensure product safety and effectiveness. Key essentials include rigorous document control to manage procedures, specifications, and records. Risk management is crucial in identifying and mitigating potential issues. Compliance with industry standards and regulatory requirements, such as ISO 13485 and FDA regulations, is paramount. Effective design and development processes, rigorous testing, and validation procedures are essential to produce safe, reliable devices. Post-market surveillance and continuous improvement are also integral, helping to monitor and enhance product performance, address customer feedback, and adapt to evolving regulatory demands. Employee training and adherence to best practices round out a comprehensive QMS.

  • green check

    Quality Management System (QMS) helps measure key quality and supply chain metrics, provides quality insights with organization-wide dashboards and reports

  • green check

    Quality Management System (QMS) provides thorough visibility with robust continuous supplier assessment process across global and local supply chains

  • green check

    Quality Management System (QMS) customizes quality management processes that ensure defect-free manufacturing and lower production costs

  • green check

    A robust Quality Management System (QMS) integrates quality processes with existing manufacturing processes thus facilitating an agile environment to shorten the product life cycle

  • green check

    Quality Management System (QMS) facilitates a closed-loop system to track all quality events across all manufacturing locations

  • green check

    Quality Management System (QMS) ensures smooth regulatory compliance across geographies

  • green check

    Quality Management System (QMS) enables deploying specialized equipment and incident management modules that monitor quality events on the factory floor

  • green check

    Quality Management System (QMS) ensures cybersecurity

  • green check

    Quality Management System (QMS) facilitates operational excellence

  • green check

    Quality Management System (QMS) allows for customizing training management to distribute programs for key personnel

  • green check

    Quality Management System (QMS) can track risk and change initiatives with a data-first mindset

  • green check

    Quality Management System (QMS) ensures meeting environmental sustainability goals

Medical Device Manufacturer quality Case study

Customer Success

Start-Up Medical Device Manufacturer and Global Distribution Company Join Forces with Shared Complaint Management System Powering an Integrated EQMS Platform

Medical Device Manufacturer quality Case study
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Medical Device Quality Management System

What is a Medical Device Quality Management System?

A Medical Device Quality Management System (QMS) is a structured framework established by medical device manufacturers to ensure consistent, safe, and effective products. It encompasses processes, procedures, and documentation control to meet industry and regulatory standards. A well-implemented QMS adheres to regulations like ISO 13485 and FDA requirements, focusing on risk management, product development, manufacturing, and post-market surveillance to maintain high-quality and safe medical devices. Accepted internationally by the FDA and other countries, ISO 13485 is the international standard that applies to all 165 member countries of the International Organisation for Standardization (ISO). It is used as the parameter to measure a medical device manufacturer’s quality management system (QMS), including quality management system effectiveness, regulatory compliance, and customer requirements. ISO 13485:2016 has become the backbone of the integrated MDSAP (Medical Device Single Audit Program) introduced in 2019. Medical device manufacturers, raw material suppliers to these manufacturers, surgical medical device manufacturers, and sterile medical device manufacturers across the region must adhere to global ISO 13485 standards to comply with international markets’ requirements, including EU members, Canada, and Japan. ISO 9001 is used for implementing best practices in Quality Management Systems, and ISO 13485 focuses on risk management and documentation of procedures.

How does Medical Device Compliance Software help to align with FDA regulations?

Medical Device Compliance Software streamlines adherence to FDA regulations by automating critical aspects of the QMS. It aids in document control, change management, audit trails, and risk assessment. Additionally, it facilitates real-time visibility into quality data, supports compliance monitoring, and expedites corrective and preventive actions, ensuring that medical device manufacturers stay aligned with FDA requirements while minimizing the risk of non-compliance.

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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itek logo

Medical Device Quality Management Software (QMS) and ISO Quality Standards

ISO 13485:2016 has become the new foundation for medical device QMS or quality management software. If you haven’t started your gap analysis using quality management software, the time to start that transition is now. It is critical for medical device manufacturers and suppliers to begin implementing quality management software standards of the revised ISO 13485:2016, as the allotted three-year changeover period may not provide adequate time for all organizations to transition. ComplianceQuest can help companies to effectively plan, monitor, and improve the transition to quality management software as well as the overall quality management.

Medical device and iso 13485 software
Establish Medical Device Quality Management Software

Using CQ to Establish Medical Device Quality Management Software

ComplianceQuest Modern Cloud Enterprise Quality Management System (EQMS) supports the latest edition of ISO 13485:2016 by automating your entire quality management system requirements and maintaining full traceability. CQ’s Enterprise Quality Management System (EQMS) Suite was designed from the ground-up to be not only extremely user-friendly at all levels but also provide a very powerful platform to scale regardless of the size of the company. ComplianceQuest helps you organize your company’s ISO 13485:2016 requirements, improving productivity while easily helping auditors and notified bodies to find what they need quickly and effortlessly.

ComplianceQuest offers comprehensive ISO 13485 software designed specifically for managing the medical device QMS. With this software, you can efficiently supervise all aspects of your QMS processes and guarantee that your medical device products and services adhere to all necessary regulatory standards.

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Quality-centric Companies Rely on CQ QMS

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Frequently Asked Questions

  • ComplianceQuest is a modern cloud Enterprise Quality & Safety Management System (QHSE) that covers all the requirements of ISO 9001:2015 and helps with automating the workflow. CQ has significantly reduced the effort involved in maintaining ISO 9001:2015 Quality Management System with process automation while maintaining full traceability. In addition, it provides a complete view of the organization’s data related to the performance and effectiveness of the quality and compliance management systems.

  • The current ISO 13485 standard emphasizes integrating internal processes to minimize risk within the organization. This integration includes:

    • Product planning

    • Corrective Actions and Preventive Actions (CAPA)

    • Verification, validation, and revalidation

    • Monitoring, testing, and traceability

    • Risk management documentation in product realization

    Another major change in the current version of ISO 13485 is regarding outsourcing. According to the new version of the ISO 13485 standard, companies that are contracted for the development, design, or servicing of medical devices must also meet ISO 13485 standards.

  • Quality System Regulation (QSR) or FDA 21 CFR Part 820 defines Current Good Manufacturing Practice (cGMP) regulations. Established by FDA, 21 CFR Part 820 focuses on ensuring the products meet requirements and specifications consistently. These requirements focus on the safety and effectiveness of medical devices as directed by FDA. All medical device manufacturers are mandated to undergo FDA inspections as part of FDA 21 CFR 820 compliance requirment.

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