Dot Compliance

OCTOBER 10, 2022

The process of ensuring medical equipment will operate safely and correctly is known as medical device validation. Each manufacturer employee that works on creating medical equipment must complete the necessary training. Personnel must have clear understanding of both medical device process and medical device procedure.

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Dot Compliance

OCTOBER 10, 2022

The process of ensuring medical equipment will operate safely and correctly is known as medical device validation. Each manufacturer employee that works on creating medical equipment must complete the necessary training. Personnel must have clear understanding of both medical device process and medical device procedure.

FDA 52

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Dot Compliance

FEBRUARY 8, 2022

The digital revolution and IoMT (Internet of Medical Things) has transformed the healthcare landscape. Software and connected devices are now being used to power disruptive medical technologies and solutions. What is Software as a Medical Device (SaMD)?

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SQA

FEBRUARY 15, 2023

Following the draft consultation in November 2022, the NMPA announced the issuance of the Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility of the Quality and Safety of Medical Devices , which will come into force on 01 March 2023. ” The requirements for providers (e.g.,

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HIT Consultant

FEBRUARY 6, 2023

For example, only 3% of the 2,728 US digital health deals since 2011 have focused on women’s health. Now companies have realized that wellness benefits such as medical screenings, counseling, fitness programs, and competitions are far more cherished.

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Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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Health Law Advisor

MAY 3, 2022

In this month’s post, in the medical device realm I explore what kinds of inspection citations most often precede a warning letter. We have just gone through an extraordinary two years where, in unprecedented fashion, FDA’s inspection process was essentially shut down. Just a short while ago FDA recommenced inspections.

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