Dot Compliance

JANUARY 30, 2024

Introduction: In the fast-evolving landscape of the medical device industry, ensuring the highest quality standards is paramount. By streamlining workflow processes, medical device companies can allocate resources more efficiently, freeing up personnel to focus on strategic tasks rather than routine administrative functions.

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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

Navigating the complexities of ISO 13485 can be overwhelming for medical device manufacturers. This international standard sets the benchmark for quality management systems (QMS) in the medical device industry, ensuring product safety and efficacy.

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Dot Compliance

JUNE 16, 2022

Millions of dollars are lost by manufacturers every year due to regulatory non-compliance issues and related lawsuits. We continuously hear of infractions and warnings issued to companies for lack of regulatory compliance. The FDA 21 CFR Part 820 is the mandatory standard for medical devices distributed in the US.

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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

JULY 10, 2020

Plus, subscribe here to start receiving our exclusive, in-depth analysis of new developments in the medical device industry. If you have any questions or comments, don’t hesitate to get in touch. References FDA (2020, May).

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