Healthcare IT Today

JUNE 27, 2023

Food and Drug Administration (FDA) has recognized the problem and issued multiple guidance documents over the years—as recently as this March —to ensure the cybersecurity of medical devices. Although none of the FDA recommendations are legally enforceable, device manufacturers no longer have a choice but to comply.

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Ransomware FDA Governance Hospitals 119

Healthcare IT Today

SEPTEMBER 12, 2023

A major justification for President Biden’s tax hike proposal is to shore up the tenuous finances of Medicare whose trust fund is forecasted to be depleted by 2028. Historically, it is the most prolific driver of family bankruptcy, and now it is on its way to bankrupting our country collectively.

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Nurses Doctors Medicare Medicare 78

Dot Compliance

JUNE 16, 2022

Government regulators have been doing their best to ensure that patients receive the safest and most efficient device possible. The two most relevant quality regulations for medical device manufacturers are the FDA 21 CFR Part 820 and the ISO 13485:2016. What are the main regulations governing medical device QMS?

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FDA Regulatory Compliance Compliance Governance 52

Dot Compliance

JANUARY 14, 2022

between 2021, and 2028. Common risk areas often include (but aren’t limited to): Cybersecurity Audit management Government pricing General data protection regulation. FDA’s Safer Technologies Program (SteP) for Medical Devices. The life science sector is one of the country’s most lucrative industries.

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Compliance FDA Regulatory Compliance Governance 52

SQA

MAY 24, 2023

Having analyzed over 2000 responses received, the government will now take forward legislation to reform of the UK clinical trials regulatory framework that will: Ensure patients and their safety are at the focus of all clinical trials and bring the benefits of clinical trials to everyone.

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SQA

OCTOBER 18, 2024

The sponsor is also responsible for implementing a Quality Assurance system to ensure that the clinical trial is conducted and data generated, documented, and reported in compliance with the protocol and Good Clinical Practice (GCP) guidelines issued by the CDSCO Directorate General of Health Services Government of India.

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FDA Compliance Public Health World Health 52

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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