Dot Compliance

JANUARY 30, 2024

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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Dot Compliance

SEPTEMBER 27, 2024

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.

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Dot Compliance

SEPTEMBER 13, 2024

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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Dot Compliance

SEPTEMBER 2, 2024

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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Dot Compliance

JUNE 16, 2022

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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Exeed Regulatory Compliance

JULY 6, 2020

We will cover the other types of medical PPE in another video. Let us know your questions or comments and subscribe here to start receiving our exclusive, in-depth analysis of new developments in the medical device industry.

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Exeed Regulatory Compliance

APRIL 2, 2020

Market for interconnected medical devices is projected to grow but the regulatory pathway is still evolving. Medical device industry is changing fast! Technology is driving rapid innovation and medical devices are becoming more interconnected, and smart!

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