Exeed Regulatory Compliance

JULY 6, 2020

Let us understand how they help and how FDA plans to regulate them. In this article, we explain the FDA requirements, and guidance for face masks when they are used for a medical purpose such as diagnosis, or cure, mitigation, treatment of prevention of disease. We will cover the other types of medical PPE in another video.

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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. A new FDA guidance offers helpful recommendations for design and premarket submission. Medical device industry is changing fast! You can think of many other examples in your daily life.

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Exeed Regulatory Compliance

JULY 10, 2020

The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. We recently discussed the FDA’s policy for Face Masks during COVID-19. So, there are two parts to the definition of these devices – what they are and how they are used.

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Dot Compliance

JANUARY 7, 2025

Enhance compliance: Ensure compliance with FDA regulations, including CGMP and 21 CFR Part 11 , through automated compliance checks and audit trails. Enhance regulatory compliance: Comply with Good Laboratory Practices (GLP) and other relevant regulations.

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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 QMS supports the manufacturers, leading to ISO confirmation and FDA compliance.

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Drug & Device Law

SEPTEMBER 2, 2022

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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