Remove 2017 Remove FDA Remove Licensing Remove Public Health
article thumbnail

Digital Documentation: How PDFs Can Help Providers Expedite Care

HIT Consultant

The legislation mandated healthcare providers to modernize their internal recordkeeping, allowing for the swifter dissemination of medical information to support public health efforts and better medical care. Software matters: A snapshot of the digital transformation at a large health system.

FDA 98
article thumbnail

$11M for North Carolina Work-Based Rehab Raises Concerns

Kaiser Health News

In presentations, they often share a 2017 study — conducted by an independent research institute at TROSA’s request — which found TROSA saves the state nearly $7.5 Other graduates interviewed for this article talked about using the moving skills or commercial driving licenses they gained to obtain full-time jobs.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April

SQA

MDCG 2023-3 , Questions and Answers on Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices, provides additional information on key vigilance terms. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40
article thumbnail

EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Bill of Health

Beyond the health care sector-specific Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), this mix of AI & Data related regulatory requirements stems from a series of generalized, cross-sectoral EU laws of the last 5 years.

FDA 282
article thumbnail

SQA Regulatory Surveillance Summary 6 | Monthly Update 2021

SQA

Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products – General Principles, 15 September 2021. The agencies conduct PSA meetings under the auspices of the confidentiality arrangement between the European Commission, the EMA, and the FDA. European Medicines Agency (EMA). The EMA and the U.S.

FDA 52
article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

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. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively.

article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023

SQA

In addition, it contains essential recommendations to avoid complications and protect public health. The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products.

FDA 40