Dot Compliance

MARCH 26, 2025

In medical device manufacturing, companies must follow specific standards to ensure compliance. ISO 13485 and ISO 14971 are two key standards that guide the safety and quality of medical devices. Both standards are crucial, but they address different aspects of compliance.

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Dot Compliance

JANUARY 7, 2025

With the level of regulatory scrutiny that companies face, along with customer expectations, and the complexity of products and services, organizations must excel in all operations to stay ahead. Training Management Training plan creation: Develop and manage training plans that align with organizational needs and regulatory requirements.

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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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