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Avoid costly non-conformances in manufacturing by using our comprehensive, compliant QMS.
Resolve FDA Form 483 or warning letter issues efficiently with our QMS remediation and ensure timely, effective compliance.
Streamline your organization's processes with our expert QMS design and implementation, following FDA, ISO, and MDSAP standards.
Empower your team with our QMS training that helps them understand roles and ensure ongoing compliance with evolving standards.
Optimize your quality management with a robust evaluation that verifies your compliance to specific audit criteria.
Reduce execution risk by working with a medical device software company known for over 1,600 medical devices successfully developed.
Leverage our proprietary platform architecture and reduce development timelines by up to 60%.
Our in-house team of specialized engineers will bring your medical device from concept to reality with precision and care.
Let Vantage MedTech show how to bring your idea from concept to prototype to FDA/CE approval with a free custom project analysis.
A quality management system (QMS) for medical devices is a structured system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
It helps manufacturers consistently meet regulatory requirements and customer expectations for medical device products.
By focusing on risk management, design controls, and continual improvement, a QMS ensures the safety and efficacy of medical devices.
ISO 13485 and ISO 9001 are both standards for quality management systems, but they serve different purposes.
ISO 13485 is specifically designed for the medical device industry. It focuses on the safety and efficacy of medical devices. Requirements include regulatory compliance, risk management, and specific documentation for the design and manufacture of medical devices.
Comparatively, ISO 9001 is more general. It’s applicable to any organization seeking to improve customer satisfaction and process efficiency.
In medical technology, QC stands for quality control. It refers to the procedures and processes used to ensure the quality and reliability of medical products and services.
QC involves the systematic inspection, testing, and verification of products and services to meet specific standards and requirements.
Quality control is vital in medical technology to prevent defects, ensure patient safety, and maintain regulatory compliance.
In the context of medical device manufacturing, QA generally comes first. It focuses on preventing defects in medical devices by ensuring processes and procedures are in place to produce quality products before development begins.
QC, on the other hand, occurs after the product is developed, but before it’s released to the market. It involves testing and inspection to ensure the final products meet the required quality standards.
ISO 13485 is not a QMS in and of itself, but it is a standard used to govern QMSs. It provides a framework for companies to ensure consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
ISO 13485 is recognized internationally and is often required for regulatory purposes. Therefore, any medical device manufacturer’s QMS should be designed with ISO 13485 in mind.