Medical Devices l Quality Management System
ISO 13485
ISO 13485 entails the requirement for the quality management stem for organizations that needs to demonstrate their ability to provide a medical device and related services that are in line with customer requirements and regulatory guidelines.
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ISO 13485 – Medical Devices l Quality Management System - Requirement for regulatory purpose
ISO 13485 entails the requirement for the quality management stem for organizations that needs to demonstrate their ability to provide a medical device and related services that are in line with customer requirements and regulatory guidelines.
It is noteworthy that such organizations can be of any size and can be involved in any stage of the overall value chain of concerned devices i.e.: design, development, production, storage, etc. Moreover, the vendors of such organizations can also get benefit from their compliance with the said standard.
Requirements for ISO 13485
The main goal is to comply with the complete medical device regulatory requirements. It contains concrete guidelines for manufacturing, installing, and servicing medical devices and ask for:
- Implementation of QMS with subjected framework guidelines
- Risk management approach to product development and product realization
- Haromiozed process validation
- Compliance with statutory and regulatory requirements
- Effective product traceability and recall systems
Taking into account the modern industrial requirements, ISO 13485 is reviewed after every five years.
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ISO 13485 is organized into the following sections:
- Scope
- Normative References
- Terms & Definitions
- Quality Management System
- Management Responsibility
- Resource Management
- Product Realization
- Measurement, Analysis & Improvement
Benefits of ISO 13485
The Implementation of ISO 13485 tend to offer following benefits;
13485 causes a decrease in safety and legal risks and creates more healthy work environments for delivering quality medical devices and related services.
It is crucial to manufacturers, designers, and distributors of medical equipment. In addition, suppliers and service providers can enhance an organization's marketability as more and more manufacturers require certification to do business with a vendor.
ISO 13485 provides a tool for a thorough audit so that we can test the system's efficiency and effectiveness efficiently.
It provides the manufacturer with a higher confidence level in consistently achieving and maintaining compliance with regulatory requirements.
International recognition, especially in major global markets
Higher customer satisfaction as a direct result of a better product
Help meeting regulatory requirements and compliance of other standards
More efficient documentation of techniques, methods, and procedures
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Step 1
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Step 2
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Step 3
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Conclusion
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