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Health Industry Cybersecurity: Managing Legacy Technology

WEBOn March 2nd, 2023, the Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG) published a guidance, “Health …

Actived: 2 days ago

URL: https://www.medicept.com/2023/03/30/health-industry-cybersecurity-managing-legacy-technology-security-hic-malts/

Understanding FDA’s New Guidance Document on Human Factors …

WEBHuman Factors Engineering is a crucial part of ensuring the safety and effectiveness of medical devices. Human factors testing is valuable when designing …

Category: Medical Go Health

Reprocessing Medical Devices in Health Care Settings: Validation

WEBThe FDA guidance document, titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” includes recommendations medical …

Category: Medical Go Health

Securing Updated and Necessary Statutory Evaluations Timely Rule

WEBIn the Trump Administration’s final days, the Department of Health and Human Services (HHS) has changed the US Food and Drug Administration’s (FDA) …

Category: Food Go Health

Health Hazard Analysis Tips

WEBHealth hazard analyses (HHAs) are a necessary part of the medical device manufacturing process since the FDA revised Medical Device Good Manufacturing …

Category: Medical Go Health

NEW Draft Guidance from FDA

WEBThe use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical …

Category: Health Go Health

A Focus on the Challenges with Utilizing Remote Monitoring

WEBRemote patient monitoring (RPM) technology allows healthcare providers to monitor patients without requiring them to be physically present in a healthcare facility. …

Category: Health Go Health

What Startups Should Know

WEBReimbursement is defined as the process of a public or private third-party payers compensating a provider for the costs of a treatment. The third party can include …

Category: Health Go Health

Understanding FDA’s NEW Draft Guidance on the De Novo eSTAR …

WEBOn September 29, 2023, the FDA issued a new draft guidance document, “Electronic Submission Template for Medical Device De Novo Requests,” which formally …

Category: Medical Go Health

Digital Health Innovation and Regulatory Compliance

WEBDigital Health Innovation and Regulatory Compliance. Advances in digital health technology and innovation are picking up speed as wireless communications …

Category: Health Go Health

New Guidance Released on EU MDR Vigilance Terms and Concepts

WEBThe EU Medical Device Coordination Group has recently released document MDCG 2023-3 titled “Questions and Answers on vigilance terms and concepts as …

Category: Medical Go Health

FDA Recognizes NEW Key Cybersecurity Standard

WEBOn November 7, 2023, FDA formally recognized a new cybersecurity standard titled ANSI AAMI SW96:2023 Standard for medical device security – Security risk management for …

Category: Medical Go Health

Risk Management Series

WEBHarm. Harm is defined by the Standard as “injury or damage to the health of people, or damage to property or the environment.”. The definition used to be “physical …

Category: Health Go Health

Using Human Factors Evaluation Outputs to Drive Risk

WEBHuman Factors, Risk, and Inputs Page 1 of 11 August 2014 Using Human Factors Evaluation Outputs to Drive Risk Analysis and Design Inputs Forward: MEDIcept is very …

Category: Health Go Health

Risk Management Series – Part 5: Assigning Harms and Severity

WEBOne of the most challenging elements of risk analysis is the assignment of Harms and Severities to a particular hazardous situation. On the surface, describing the …

Category: Health Go Health

New Brazil Regulation for Medical Devices Now In Effect – Steps to …

WEBThe new medical device regulation for Brazil, Regulation RDC No. 751/2022, issued on 21 September 2022, is now in force as of 01 March 2023. The Brazilian …

Category: Medical Go Health

MHRA Releases Roadmap of Future UK Medical Device Regulation

WEBThe UK Medicines and Healthcare products Regulatory Agency (MHRA) has revealed a roadmap for medical device regulation, aiming to prioritize patient safety and …

Category: Medical, Medicine Go Health

Part 6: Estimating Probability of Occurrence

WEBFor single-use devices, it’s pretty simple: the Probability of Occurrence of Harm is the likelihood that the harm occurs per every 1,000; 10,000; 1,000,000, etc. …

Category: Health Go Health

Risk Management Series

WEBForeword. In our last article, Part 2: Using Fault Trees to Focus and Simplify Risk Analysis, we described the basic approach for conducting a Fault Tree Analysis …

Category: Health Go Health