ANVISA ESPR for Medical Devices in Brazil : RDC 848/2024
The Essential Safety and Performance Requirements (ESPR) serve as the backbone for ensuring that medical devices are not only effective...
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Artixio is a global leader in providing exceptional quality management services, ensuring the highest standards for medical devices and diagnostic companies worldwide. With a commitment to excellence, Artixio helps these companies navigate complex regulatory landscapes, ensuring their products meet and exceed the stringent quality requirements.
Quality Management
Service
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Quality Management System Consulting and Implementation (ISO 13485, 21 CFR 820, MDSAP, Indian Medical Device Regulations)
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Audit Support (GMP, ISO 13485, MDSAP)
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Standard Operating Procedures Authoring & Harmonization
Artixio provides specialized Quality Consulting & Audit services to clients from pharmaceutical, medical devices and other industries. Artixio's Quality Management team have decades of experience across different therapeutic areas right from the early development to post marketing stage.
Quality Services
Quality Management System (QMS) for Medical Devices
Regulations & Standards Governing Medical Devices
There are several regulations and standards that govern the Quality Management Systems (QMS) for medical devices:
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ISO 13485:2016: This is an internationally recognized standard for a QMS specific to the medical device industry. Medical device manufacturers marketing and selling in the EU most likely comply with this standard.
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Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR): These are also requirements for quality management systems for manufacturers selling in the EU.
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FDA’s regulation 21 CFR Part 820 (Quality System Regulations - QSR): This is the mandatory standard for medical devices distributed in the US. The FDA recently issued the Quality Management System Regulation (QMSR) Final Rule to amend the device CGMP requirements of the QS regulation, incorporating by reference ISO 13485:2016.
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Medical Devices Rules 2017 (MDR): This is a regulation in India.
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Medical Device Single Audit Program (MDSAP): This is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements. The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan, and the United States.
These regulations and standards cover various aspects of a QMS, including but not limited to, management responsibility, quality audits, personnel, design controls, document controls, purchasing controls, identification and traceability, production and process controls, acceptance activities, and handling of nonconforming products.
Requirements of a Quality Management System
The requirements for a Medical Device Quality Management System (QMS) can vary depending on the specific regulatory jurisdiction, but they generally include the following key elements:
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Management Responsibility: The organization’s management must demonstrate its commitment to the development and implementation of the QMS and continually improve its effectiveness.
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Quality Audits: Regular internal audits are required to ensure that the QMS is effectively implemented and maintained.
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Personnel: The organization must ensure that all personnel performing work affecting product quality are competent, based on appropriate education, training, skills, and experience.
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Design Controls: The organization must establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
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Document Controls: The organization must control all documents that form part of the QMS.
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Purchasing Controls: The organization must ensure that all purchased or otherwise received product and services conform to specified purchase requirements.
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Identification and Traceability: The organization must identify the product by suitable means throughout product realization, and control the unique identification of the product where traceability is a requirement.
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Production and Process Controls: The organization must plan and carry out production and service provision under controlled conditions.
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Acceptance Activities: The organization must carry out inspections and tests to verify that the product meets defined criteria.
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Handling of Nonconforming Products: The organization must ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.
These requirements are designed to ensure that medical devices are designed and manufactured to the highest quality standards. It’s important to note that these are general requirements and specific regulations such as ISO 13485:2016, FDA’s QS Regulation, and others may have additional or more specific requirements.
A Medical Device Quality Management System (QMS) is a structured system of procedures and processes that a manufacturer of medical devices has in place to ensure that their products are safe and effective for their intended use. It covers all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more.
One of the most recognized standards for a Medical Device QMS is ISO 13485:2016. This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It applies to organizations regardless of their size and type.
In the United States, the FDA’s Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices (CGMP) is also a key regulatory framework for medical device QMS. The FDA recently issued the Quality Management System Regulation (QMSR) Final Rule to amend the device CGMP requirements of the QS regulation (21 CFR Part 820), incorporating by reference ISO 13485:2016.
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