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QMS for Medical Software and Medical Device

Medical Device QMS, Medical Software


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Enterprise Quality Management System – QMS Medical Software

QMS Medical Software

Implementing Quality Management System (QMS) involves compliance 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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Quality Management System(QMS) Medical Software

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.

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 software QMS 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

  • Product planning
  • Corrective Actions and Preventive Actions (CAPA)
  • Verification, validation, and revalidation
  • Monitoring, testing, and traceability
  • Risk management documentation in product realization
Importance of Medical Device QMS and Medical Software

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:

  •  Importance of Medical Device QMS : 1
    Enterprise-wide data visibility of both quality and safety parameters
  •  Importance of Medical Device QMS : 2
    Seamless workflows and business processes
  •  Importance of Medical Device QMS : 3
    Easy setup for multiple standards like ISO 9001, ISO 45001, OHSAS 18001, ISO 9000:2008
  •  Importance of Medical Device QMS : 4
    Predictive insights for quality; proactive approach to safety
  •  Importance of Medical Device QMS : 5
    Aligning people and processes
  •  Importance of Medical Device QMS : 6
    Reducing the cost due to inefficient safety or quality process
  •  Importance of Medical Device QMS : 7
    Better manage risk across two misaligned systems

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

  • Essentials of a QMS for Medical Devices 1
    Quality Management System(QMS) helps measure key quality and supply chain metrics, provides quality insights with organization-wide dashboards and reports
  • Essentials of a QMS for Medical Devices : 2
    Quality Management System(QMS) provides thorough visibility with robust continuous supplier assessment process across global and local supply chains
  • Essentials of a QMS for Medical Devices : 3
    Quality Management System(QMS) customizes quality management processes that ensure defect-free manufacturing and lower production costs
  • Essentials of a QMS for Medical Devices : 5
    A robust Quality Management System(QMS) integrates quality processes with existing manufacturing processes thus facilitating an agile environment to shorten the product life cycle
  • Essentials of a QMS for Medical Devices : 6
    Quality Management System(QMS) facilitates a closed-loop system to track all quality events across all manufacturing locations
  • Essentials of a QMS for Medical Devices : 7
    Quality Management System(QMS) ensures smooth regulatory compliance across geographies
  • Essentials of a QMS for Medical Devices : 8
    Quality Management System(QMS) enables deploying specialized equipment and incident management modules that monitor quality events on the factory floor
  • Essentials of a QMS for Medical Devices : 9
    Quality Management System(QMS) ensures cybersecurity
  • Essentials of a QMS for Medical Devices : 10
    Quality Management System(QMS) facilitates operational excellence
  • Essentials of a QMS for Medical Devices : 11
    Quality Management System(QMS) allows for customizing training management to distribute programs for key personnel
  • Essentials of a QMS for Medical Devices : 12
    Quality Management System(QMS) can track risk and change initiatives with a data-first mindset
  • Essentials of a QMS for Medical Devices : 13
    Quality Management System(QMS) ensures meeting environmental sustainability goals

Medical Device Quality Management Systems and FDA Regulations

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, Japan, among others. ISO 9001 is used for implementing best practices into Quality Management System and ISO 13485 focuses on risk management and documentation of procedures.

 

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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.

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.

Frequently Asked Questions

How to automate Quality Management System(QMS) with ISO 9001 compliance?
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.
What are the new updates in ISO 13485:2016?

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.

What is FDA 21 CFR Part 820?
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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