Dot Compliance

MARCH 7, 2024

Digital transformation has ignited a change in the medical device industry, one that leverages technology to create life-saving devices. Not just as a component of a medical device but as the medical device itself. This clear distinction is what’s known as Software as a Medical Device (SaMD).

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Healthcare IT Today

FEBRUARY 15, 2024

To mitigate this, continuous investment in cybersecurity measures and adding modern security and compliance protocols is essential. If unaddressed, this could lead to significant data breaches, undermining the integrity of AI systems in healthcare, like those used in modern EHRs and medical coding.

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Dot Compliance

SEPTEMBER 2, 2024

This international standard sets the benchmark for quality management systems (QMS) in the medical device industry, ensuring product safety and efficacy. We’ve created a comprehensive ISO 13485 audit checklist to help you streamline your audit process and improve your chances of compliance.

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HIT Consultant

OCTOBER 10, 2022

In addition to applications that enable more rapid scaling of hospital capacity and the deployment of more devices to generate better data, healthcare applications include wirelessly powered medical devices that don’t limit patient mobility within a hospital room or at home, which can result in better compliance rates.

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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.

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Healthcare Law Blog

APRIL 13, 2022

On March 18, 2022, AdvaMed announced updates to the Code of Ethics on Interactions with Health Care Professionals (“Code”), a voluntary code that provides medical technology companies with guidance on ethically compliant interactions and relationships with healthcare professionals. The changes will take effect on June 30, 2022.

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Dot Compliance

FEBRUARY 3, 2022

Let’s look at what’s on the horizon for the medical device industry in 2022 and how manufacturers can achieve multiple goals by digitizing their quality operations. Best Practices for Medical Devices, AAMI, September 29, 2021 2 New draft guidance to support risk-based computer software assurance,ISPE Boston, November 7, 2019.

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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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HIT Consultant

JUNE 12, 2024

Additionally, localized production enables more flexible scaling of capacity to meet demand variations and ensures compliance with regulations governing transportation and distribution.

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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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Hall Render

MARCH 1, 2023

No new enforcement actions have been settled since 2021, but Sunshine Act compliance continues to be an area poised for enforcement priority. Enforcement Between October 2020 and May 2021, three enforcement actions involving both the Sunshine Act and Anti-Kickback Statute violation allegations were settled.

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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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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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