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ISO 13485 vs ISO 9001: Key Differences

Dot Compliance

Regulatory Focus ISO 13485 is specifically aligned with the regulatory requirements of the medical device industry. It mandates detailed procedures for traceability, enabling the tracking of devices from raw materials to the end-user. The post ISO 13485 vs ISO 9001: Key Differences appeared first on Dot Compliance.

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Revolutionizing Complaint Management in Medical Device with AI-Integrated Quality Management Software

Dot Compliance

Introduction: In the fast-evolving landscape of the medical device industry, ensuring the highest quality standards is paramount. This proactive approach helps medical device companies minimize the likelihood of recurrent issues, ensuring compliance with regulatory standards and safeguarding patient safety.

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How ISO 13485 Boosts Medical Device Quality

Dot Compliance

The medical device industry balances innovation with patient safety. At the center of ensuring the reliability and effectiveness of these devices is ISO 13485, a globally recognized standard for quality management systems (QMS). ISO 13485: Key Takeaways ISO 13485 provides a framework for medical device quality systems.

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What to Know about IEC 62304 and Why It’s Important for SaMD

Dot Compliance

Digital transformation has ignited a change in the medical device industry, one that leverages technology to create life-saving devices. Not just as a component of a medical device but as the medical device itself. This clear distinction is what’s known as Software as a Medical Device (SaMD).

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Pass Your ISO 13485 Audit with This Checklist

Dot Compliance

This international standard sets the benchmark for quality management systems (QMS) in the medical device industry, ensuring product safety and efficacy. We’ve created a comprehensive ISO 13485 audit checklist to help you streamline your audit process and improve your chances of compliance.

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A Step-by-step guide to Medical Device Quality System Management

Dot Compliance

Maintaining compliance with safety and quality standards is a significant issue in medical device manufacturing. Millions of dollars are lost by manufacturers every year due to regulatory non-compliance issues and related lawsuits. The QMS supports the manufacturers, leading to ISO confirmation and FDA compliance.

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Closing the Cell Therapy Access Gap with Closed Manufacturing Systems

HIT Consultant

Additionally, localized production enables more flexible scaling of capacity to meet demand variations and ensures compliance with regulations governing transportation and distribution.