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.

COVID-19 52

COVID-19 FDA Medical Device Industry Public Health 52

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.

COVID-19 52

COVID-19 FDA Medical Device Industry Public Health 52

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.

FDA 52

FDA Medical Device Industry Doctors Regulatory Compliance 52

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.

FDA 52

FDA Regulatory Compliance Compliance Governance 52

Dot Compliance

FEBRUARY 3, 2022

Many of the steps device manufacturers are taking today to improve quality management and supply chain resiliency are aligned with the U.S. Food and Drug Administration’s (FDA) goals for the industry. This issue of validation has also been raised by the FDA in relation to the adoption of AI and ML by device manufacturers.

FDA 52

FDA Medical Device Industry COVID-19 Compliance 52

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.”

Medical Device Industry 59

Medical Device Industry Regulatory Compliance FDA Compliance 59