What is QMS?

Introduction

A Medical Device Quality Management System (QMS) is a structured framework of policies, processes, and procedures aimed at ensuring the safety and efficacy of medical devices throughout their lifecycle. This all-encompassing system includes critical aspects such as design, development, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, and product labeling.

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Medical devices are classified based on their risk to users, with each classification having specific regulatory requirements to ensure the production of safe and reliable products. An effective medical device QMS must align with these regulatory standards to maintain compliance.

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This article delves into the purpose of a medical device QMS, key regulatory requirements, and the pivotal role of electronic Quality Management System (eQMS) software like Orcanos in optimizing processes and ensuring compliance.

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Orcanos provides advanced medical device QMS software, integrating all QMS modules into one cohesive system. This streamlines processes such as document control, change control, employee training, audits, nonconformance, CAPA management, and more.

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To discover how Orcanos can benefit your organization, schedule a personalized demo with our software experts.

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Topics Explored in This Article:

- Definition and Importance of a Medical Device Quality Management System (QMS)

- Objectives of a Medical Device Quality Management System

- Key International Standards and Regulations for Medical Device QMS

- Fundamental Medical Device QMS Processes

- Impact of Medical Device Quality Management Software

- FAQs About Medical Device QMS

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Definition and Importance of a Medical Device Quality Management System (QMS)

A Medical Device Quality Management System (QMS) meticulously documents procedures and processes for every stage of a medical device's lifecycle. This system is crucial for maintaining quality during development, manufacturing, and distribution phases.

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For manufacturers aiming to market medical devices globally, implementing and maintaining a QMS that complies with international and national standards, guidelines, and regulations is essential. This involves establishing robust quality processes, assigning responsibilities, allocating resources, and setting timelines.

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Key QMS processes for medical device manufacturers include document control, change control, employee training, audit management, CAPA, supplier management, risk management, and complaint handling.

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Essential Medical Device Quality Management System Processes

A QMS can be managed through paper documentation or eQMS software. While manual management is possible, the increasing complexity of regulatory requirements makes it challenging. Many companies are now adopting eQMS for improved workflows, reduced costs, and cloud-based document storage.

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Orcanos offers a sophisticated eQMS solution tailored for the medical device industry, aiding companies in streamlining quality processes and achieving regulatory compliance. Our interconnected QMS modules provide comprehensive control and management of documents, changes, employee training, nonconformances, CAPAs, suppliers, and other critical processes.

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Objectives of a Medical Device Quality Management System

The primary objective of a medical device QMS is to ensure that products are safe and effective. A QMS provides a structured framework for consistent and documented processes from design through post-market surveillance.

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Implementing and maintaining a QMS is crucial for manufacturers seeking regulatory approval in their target markets. For instance, a QMS is required to obtain the CE marking in Europe, ensuring compliance with EU regulations such as the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). In the United States, the FDA mandates compliance with the Quality System Regulation (QSR) outlined in 21 CFR Part 820.

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Key International Standards and Regulations for Medical Device QMS

Medical device QMS standards and regulations vary by market. This article highlights the major standards in Europe and the United States.

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In the EU, compliance with ISO 13485:2016, MDR, and IVDR is typical. In the US, manufacturers must adhere to the FDA’s 21 CFR Part 820 (QSR).

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Key standards and regulations include:

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- ISO 13485:2016 Standard: Specifies QMS requirements for medical devices and related services.

- Medical Device Regulation (MDR): EU regulation governing the design, manufacturing, and distribution of medical devices.

- In Vitro Diagnostic Regulation (IVDR): EU regulation with stringent requirements for in vitro diagnostic devices.

- FDA 21 CFR Part 820 Regulation: Outlines QMS requirements for medical devices in the US.

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Additional requirements for QMS software validation include:

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- FDA 21 CFR Part 11: Regulates electronic records and signatures.

- EU GMP Annex 11: Provides GMP guidelines for computerized systems.

- ISPE GAMP5: Offers a risk-based approach to computerized system validation.

- ISO 13485:2016 Clause 4.1.6: Requires validation of QMS software before use.

- FDA 21 CFR Part 820.70(i): Mandates validation of software used in QMS.

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Fundamental Medical Device QMS Processes

This section covers some of the critical QMS processes as per ISO 13485:2016 and FDA 21 CFR Part 820 standards:

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- Document Control: Managing documents throughout the product lifecycle.

- Training Management: Ensuring employees are trained and competent.

- Audit Management: Conducting regular audits to ensure QMS compliance.

- CAPA Management: Implementing corrective and preventive actions to address and prevent quality issues.

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Impact of Medical Device Quality Management Software

A robust QMS is essential for ensuring product safety and effectiveness. While paper-based systems can be used, they are often inefficient and error-prone. eQMS software offers a more efficient, accurate, and compliant alternative.

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Medical device manufacturers can use eQMS to manage quality processes throughout the product lifecycle, enhancing compliance, customer satisfaction, and operational efficiency. Benefits of eQMS include automated documentation, improved traceability, better collaboration, and reduced human errors.

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Orcanos provides a comprehensive eQMS designed for the medical device industry. Our software streamlines quality processes, ensuring compliance with regulatory requirements. Features include robust document management, interconnected QMS modules, and adherence to FDA 21 CFR Part 11 and EU GMP Annex 11 standards.

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FAQs About Medical Device QMS

What Are the Two Main Quality Systems Adopted by Medical Device Manufacturers?

- The FDA 21 CFR 820 and ISO 13485:2016 are the primary quality systems adopted by medical device manufacturers.

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What is the Best Quality Management Software for Medical Devices?

- The best QMS software depends on your company’s size, complexity, specific requirements, and budget. Orcanos offers a robust solution tailored for the medical device industry.

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What Is the ISO 13485:2016 Quality Management System?

- ISO 13485:2016 specifies QMS requirements for medical devices, ensuring products consistently meet customer and regulatory requirements.

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When Is a Quality Management System (QMS) Required for Medical Devices?

- A QMS is required for medical device companies seeking to market and sell their products, ensuring compliance with FDA and EU regulations.

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When Should I Start Building a Medical Device QMS?

- The ideal time to start building a QMS is during the Design and Development phase, once sufficient information and knowledge have been gathered.

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How Long Does It Take to Fully Implement Medical Device QMS?

- Implementing a medical device QMS typically takes 3 to 9 months, with preparations recommended 18-24 months before commercialization.

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Final Thoughts

A medical device quality management system is indispensable for ensuring product safety and effectiveness. Orcanos eQMS software aids in streamlining quality management processes, making compliance easier and more efficient.

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For a comprehensive QMS software solution, schedule a demo to see Orcanos in action and discuss your specific needs with our experts.

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