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

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

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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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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Drug & Device Law

SEPTEMBER 2, 2022

The court next addressed the defendant’s motion to exclude the plaintiff’s regulatory rebuttal expert as unqualified to offer the opinions in his report. The defendant argued that the expert “ha[d] no experience in regulatory compliance for the medical device industry, and any remotely relevant experience he had ended in 1989.”

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