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  Quality  >  Medical Device Quality Management System

Medical Device QMS, Medical Software

medical device qms 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.

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QMS Medical Device Software

Implementing a Quality Management System in the medical device industry involves defining processes, procedures, and standards to ensure product safety and efficacy. Medical devices QMS System 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 QMS 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 chains. 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 systems for medical devices. The current standard on Quality Management Software emphasizes integrating internal processes to minimize risk within the organization. This QMS Software for Medical Devices integration includes:

Integrating QMS Software for Medical Devices
qms software 13485 planning

Product planning

capa for medical device qms software

Corrective Actions and Preventive Actions (CAPA)

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Verification, validation, and revalidation

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Monitoring, testing, and traceability

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Risk management documentation in product realization

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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 ISO 13485 QMS Software

While the main objective of ISO 13485 QMS Software is to ensure compliance with regulations and standards, it also has other growing importance. The ISO 13485 Quality Management System 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.

iso 13485 quality management system software

  • 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 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 QMS System 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 medical qms system.

Essentials of a Quality Management System for Medical Devices
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    Quality management system for medical devices helps measure key quality and supply chain metrics, provides quality insights with organization-wide dashboards and reports

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    A robust medical device quality management system QMS integrates quality processes with existing manufacturing processes thus facilitating an agile environment to shorten the product life cycle.

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    Medical Device QMS facilitates a closed-loop system to track all quality events across all manufacturing locations.

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    QMS in medical devices can track risk and change initiatives with a data-first mindset.

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    QMS for medical devices 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 Medical Device 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?

Ensuring compliance with FDA regulations is crucial for medical device manufacturers to maintain market access and ensure patient safety. Medical Device Compliance Software plays a pivotal role in helping companies align with these stringent requirements. Here’s how:

Medical Device Compliance Software

Streamlined Documentation and Record Keeping

  • Centralized Repository: Store all compliance-related documents in a single, accessible location.
  • Automated Updates: Ensure documents are always up-to-date with the latest regulatory standards.

Enhanced Quality Management

  • Integrated QMS: Seamlessly integrate with Quality Management Systems (QMS) to ensure continuous compliance.
  • Real-time Monitoring: Track quality metrics and compliance status in real time

Efficient Risk Management

  • Risk Assessment Tools: Identify, assess, and mitigate risks associated with medical device manufacturing.
  • Proactive Compliance: Stay ahead of potential compliance issues by addressing risks early.

Simplified Audit Processes

  • Audit Trails: Maintain detailed records of all compliance activities for easy auditing.
  • Audit Readiness: Be prepared for FDA QMS System inspections with complete and organized documentation.

Regulatory Reporting

  • Automated Reporting: Generate necessary reports for FDA QMS System submissions effortlessly.
  • Compliance Tracking: Monitor compliance status and generate alerts for non-compliance issues.

Improved Training and Competence

  • Training Management: Ensure all employees are trained on FDA regulations and company-specific compliance procedures.
  • Competency Tracking: Track and document employee training and competencies to ensure regulatory requirements are met.

Incident Management

  • CAPA Integration: Integrate Corrective and Preventive Action (CAPA) processes to handle compliance-related incidents efficiently.
  • Incident Reporting: Streamline the reporting and resolution of incidents to maintain compliance.
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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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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.

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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 systems 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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Step-by-step Guide to Implement Medical Device QMS

Implementing a Medical Device Quality Management System (QMS) is crucial for ensuring compliance with regulatory standards and maintaining high-quality standards. This guide provides a step-by-step approach to implementing a robust Medical Device QMS using the Best QMS software for medical devices.

Implement Medical Device QMS
Regulatory Requirements
Understand Regulatory Requirements

To start, familiarize yourself with regulatory requirements such as ISO 13485 and FDA regulations. Understanding these standards is vital for implementing an effective Medical Device QMS. Utilizing ISO 13485 QMS software can streamline this process.

Key Points

  • Study ISO 13485 and FDA regulations.
  • Identify specific requirements for your medical device.
  • Use medical device compliance software to ensure alignment with regulations.
Quality Objectives and Policies
Define Quality Objectives and Policies

Establish clear quality objectives and policies that align with regulatory standards. This foundation will guide your QMS implementation.

Key Points

  • Set measurable quality objectives.
  • Develop comprehensive quality policies.
  • Implement medical device quality software to manage these objectives.


Right QMS Software
Select the Right QMS Software

Choosing the right QMS software is critical. Look for software that supports medical devices and complies with ISO 13485.

Key Points

  • Evaluate different QMS software for medical devices.
  • Ensure the software supports FDA QMS System and ISO 13485 requirements.
  • Opt for the best QMS software for medical devices that offers comprehensive features.
Document Processes
Document Processes and Procedures

Document all processes and procedures to ensure consistency and compliance. This documentation is essential for audits and continuous improvement.

Key Points

  • Create detailed process documents.
  • Use medical QMS software for document management.
  • Ensure easy access and version control.
Train Your Team
Train Your Team

Training is essential for successful QMS implementation. Ensure your team understands the processes and the importance of compliance.

Key Points

  • Develop a training program.
  • Use medical device quality management system software for training tracking.
  • Conduct regular training sessions.
Risk Management
Implement Risk Management

Risk management is a critical component of a Medical Device QMS. Identify, assess, and mitigate risks associated with your medical devices.

Key Points

  • Conduct risk assessments.
  • Use quality management software for medical devices to manage risks.
  • Implement corrective and preventive actions.
Internal Audits
Conduct Internal Audits

Regular internal audits help ensure your QMS is effective and compliant with regulatory standards.

Key Points

  • Schedule regular internal audits.
  • Use QMS FDA medical device software to manage audit processes.
  • Document audit findings and corrective actions.

Inspection
Monitor and Measure Performance

Continuously monitor and measure the performance of your QMS to identify areas for improvement.

Key Points

  • Set key performance indicators (KPIs).
  • Use quality management system software medical devices for performance tracking.
  • Implement improvements based on data analysis.
Non-conformances and CAPA
Manage Non-conformances and CAPAs

Effectively managing non-conformances and Corrective and Preventive Actions (CAPAs) is essential for maintaining compliance and improving quality.

Key Points

  • Document nonconformances.
  • Use Medical device QMS software to manage CAPAs.
  • Ensure timely resolution of issues.
Continuous Improvement
Continuous Improvement

A successful Medical Device QMS is always evolving. Focus on continuous improvement to enhance quality and compliance.

Key Points

  • Regularly review and update your QMS.
  • Use QMS software 13485 to track improvements.
  • Encourage a culture of quality and compliance.

Best Practices for Successful Implementation of Quality Management Software for Medical Devices

Implementing Quality Management Software (QMS) for medical devices is critical in ensuring compliance with industry standards and regulations, such as ISO 13485 and FDA requirements. A robust QMS not only helps maintain high-quality standards but also enhances overall operational efficiency. Here are some best practices for successfully implementing quality management software for medical devices.

Implementation of Quality Management Software for Medical Devices

Understanding the Regulatory Requirements

  • ISO 13485 Compliance: ISO 13485 is a globally recognized standard for quality management system in medical devices industry. Ensuring that your QMS software is ISO 13485 compliant is crucial. This standard sets the framework for quality management processes and helps meet regulatory requirements.
  • FDA Regulations: The FDA has stringent requirements for medical devices. Implementing a QMS that aligns with FDA regulations ensures that your products meet safety and efficacy standards. A QMS FDA medical device compliance, is essential for market approval and patient safety.

Choosing the Right QMS Software

  • Evaluate Your Needs: Before selecting a QMS software for medical devices, assess your organization’s specific needs. Consider factors such as the size of your company, the complexity of your operations, and the regulatory requirements you need to meet.
  • Features to Look For: Ensure that the medical device QMS software includes document control, risk management, corrective and preventive actions (CAPA), audit management, and training management. The best QMS software for medical devices should integrate seamlessly with your existing systems and processes.

Integration with Existing Systems

  • Seamless Integration: Your QMS software should integrate smoothly with other systems like ERP, CRM, and manufacturing execution systems (MES). This integration ensures data flows seamlessly across different departments, improving overall efficiency and compliance.
  • Data Migration: When transitioning to a new quality management system medical device, ensure that all critical data is accurately migrated. This includes historical quality records, supplier information, and compliance documentation.

Training and Support

  • Comprehensive Training: Invest in comprehensive training programs for your staff. A well-trained team is essential for successfully implementing and using medical device quality management system software. Training should cover all aspects of the software, including user interface, key functionalities, and troubleshooting.
  • Ongoing Support: Choose a QMS provider that offers robust customer support. This support should include technical assistance, software updates, and access to best practice resources. Ongoing support ensures that your QMS remains effective and up-to-date with regulatory changes

Customization and Scalability

  • Customization: Every medical device company has unique needs. Ensure your medical device QMS software can be customized to meet your specific requirements. Customization might include tailored workflows, specific reporting capabilities, and unique compliance features.
  • Scalability: As your company grows, your QMS software should scale with you. The best QMS software for medical devices should accommodate increased data volume, additional users, and expanded functionalities without compromising performance.

Ensuring Data Integrity and Security

  • Data Integrity: Maintaining data integrity is critical in the medical device industry. Your QMS software should have robust mechanisms to ensure data accuracy, consistency, and reliability. This includes audit trails, electronic signatures, and data validation processes.
  • Security Measures: Implementing strong security measures is vital to protect sensitive information. Ensure that your medical device quality management system software complies with industry standards for data security, including encryption, access controls, and regular security audits.

Continuous Improvement

  • Regular Audits and Reviews: Conduct regular audits and reviews of your QMS to identify areas for improvement. This proactive approach helps maintain compliance and enhance the overall quality of your processes and products.
  • Feedback Loop: Establish a feedback loop to gather input from users of the QMS. This feedback can provide valuable insights into the system’s performance and areas for improvement. Continuous improvement is key to maintaining an effective Quality Management System for Medical Devices.

Partnering with a Reliable Vendor

  • Vendor Reputation: Choose a vendor with a proven track record in providing iso 13485 quality management software for medical devices. Look for testimonials, case studies, and industry recognition to ensure the vendor is reputable and experienced.
  • Ongoing Partnership: Establish an ongoing partnership with your QMS vendor. This partnership ensures you receive continuous support, updates, and improvements to your QMS software, keeping it aligned with industry best practices and regulatory changes.

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Features of the Best QMS Software for Medical Devices

In the highly regulated medical device industry, ensuring the quality and compliance of products is paramount. Implementing the best QMS software for medical devices can streamline processes, maintain compliance with regulations, and improve overall product quality. Below are six key features that define the best quality management system software for medical devices.

Features of Best QMS Software for Medical Devices

  • Compliance with ISO 13485 and FDA Regulations

    One of the critical features of the best QMS software for medical devices is its ability to ensure compliance with ISO 13485 and FDA regulations. This includes providing templates and workflows that align with these standards and ensuring that all documentation and processes meet regulatory requirements. The software should facilitate creating and maintaining compliant quality management system documentation, audits, and corrective actions.

  • Document Control and Management

    Effective document control is essential in the medical device industry. The best medical QMS software offers robust document management features that allow for secure storage, version control, and easy retrieval of documents. This includes SOPs, work instructions, design files, and other critical documents. Automated workflows for document review and approval processes ensure that only the latest versions are available to employees.

  • CAPA Management

    Corrective and Preventive Action (CAPA) management is crucial for addressing non-conformances and preventing recurrence. The best QMS software for medical devices includes a comprehensive CAPA module that systematically investigates root causes, implements corrective actions, and tracks their effectiveness. This feature ensures continuous improvement and compliance with regulatory requirements.

  • Risk Management

    Risk management is a fundamental aspect of quality management in the medical device industry. Leading QMS software for medical devices provides tools for identifying, assessing, and mitigating risks throughout the product lifecycle. This includes integrating risk management processes with other QMS processes, such as design controls, CAPA, and change management, ensuring a proactive approach to quality and compliance.

  • Supplier Quality Management

    Managing supplier quality is critical to maintaining the quality of medical devices. The best QMS software includes features for supplier qualification, performance monitoring, and audit management. This ensures that all suppliers meet the necessary quality standards and that any issues with supplier performance are promptly addressed. The software should provide a centralized repository for all supplier-related information and facilitate communication and collaboration with suppliers.

  • Training Management

    Ensuring that employees are adequately trained is essential for maintaining compliance and product quality. The best quality management system software for medical devices includes a training management module that automates employee training assignments, tracking, and documentation. This ensures that all personnel have the necessary skills and knowledge to perform their duties effectively and in compliance with regulatory requirements.

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Best QMS Software for Medical Devices

Some of the best medical device quality management system (QMS) software options include ComplianceQuest, MasterControl and Trackwise. However, as we move into an AI and data-powered world, ComplianceQuest is becoming the preferred choice and leading provider of QMS software for medical devices, pharma/biotech, and the overall life sciences sector.

ComplianceQuest

ComplianceQuest is the top choice leading provider for QMS software in the medical device industry. It offers a comprehensive solution that ensures compliance with ISO 13485, FDA regulations, and other global standards. This cloud-based platform integrates seamlessly with existing processes, providing robust document control, risk management, and audit management capabilities.

Key Features

  • Full compliance with ISO 13485 software requirements
  • Advanced document control and management
  • Real-time risk management and mitigation
  • Efficient audit management
  • Comprehensive training and competency tracking

IQMS

IQMS provides a QMS solution tailored to the medical device industry, ensuring compliance with regulatory standards and enhancing quality management.

Key Features

  • Document control and management
  • Compliance with ISO 13485 and FDA regulations
  • Risk management
  • Supplier management
  • Audit management

AssurX

AssurX offers a QMS solution for some medical device companies, enabling compliance processes and streamlining QMS workflow.

Key Features

  • Document control and management
  • CAPA management
  • Compliance with FDA and ISO 13485
  • Risk management
  • Supplier quality management

Greenlight Guru

Greenlight Guru provides a platform that streamlines compliance and quality management for the medical device industry.

Key Features

  • Easy compliance with FDA and ISO 13485
  • Design control management
  • Risk management and assessment
  • CAPA management
  • Document contro

Arena Solutions

Arena Solutions offers cloud-based QMS software for medical devices, facilitating collaboration and compliance with regulatory standards.

Key Features

  • Document control and management
  • Quality process automation
  • Compliance with FDA and ISO 13485 Software
  • Supplier management
  • Risk management

MasterControl

MasterControl serves medical device companies streamline specific quality processes and ensure compliance with regulatory standards.

Key Features

  • Document control and management
  • Training management
  • Supplier quality management
  • Risk management
  • Compliance with FDA and ISO 13485 standards

ETQ Reliance

ETQ Reliance is a QMS platform that caters to certain needs of the medical device industry, enabling compliance and quality across some processes.

Key Features

  • Comprehensive document control
  • Audit management
  • Risk management
  • Compliance with FDA and ISO 13485
  • Training and competency management

Veeva Systems

Veeva Systems offers a QMS for medical devices designed to automate quality management and ensure regulatory compliance.

Key Features

  • Document control
  • Quality event management
  • Change control
  • Compliance with ISO 13485 and FDA regulations
  • Risk management

QAD CEBOS

QAD CEBOS provides a robust QMS solution for the medical device industry, helping companies maintain high standards of quality and compliance.

Key Features

  • Document control and management
  • CAPA management
  • Supplier quality management
  • Compliance with FDA and ISO 13485
  • Audit management

Sparta Systems

Sparta Systems offers a comprehensive QMS platform, TrackWise, which is widely used in the medical device industry to ensure quality and compliance.

Key Features

  • Document management
  • CAPA management
  • Supplier quality management
  • Compliance with FDA and ISO 13485
  • Audit management

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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