Fangconsulting.com

Regulatory Pathways For Vaccine Approvals Fang Consulting

WebA news release from the National Institutes of Health in March 2021 indicated that the Astra Zeneca trial included over 32,000 participants across 88 sites in …

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URL: https://www.fangconsulting.com/blog/the-long-and-winding-road-regulatory-pathways-for-vaccine-approvals/

Public Health Emergency Expiring What Will Happen To EUAs

WebThe public health emergency declaration was first issued in the US on January 31 st, 2020, and has been extended several times since then. The current …

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IN VITRO DIAGNOSTIC REGULATION

WebClass D – High patient risk and high public health risk High-risk diseases, blood screening of blood components, determining the infectious load of a life-threatening disease; This …

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Regulatory Affairs and Medical Device Consulting

WebCustomized Consulting Services. Fang Consulting’s collective expertise and experience in the medical device industry ensures the successful execution of regulatory and quality …

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Medical Device Consulting Company FDA Regulatory + MDR …

WebWhether your goal is EU MDR, IVDR or FDA compliance, we’ve got the consultant for you. Our team has more than 40 years of experience in regulatory affairs and quality …

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US Medical Device Consulting Fang Consulting

WebThe Fang Consulting team have a solid understanding of medical device development and can partner with you from development, through testing and submission, to a smooth …

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Tracy Eberly Discusses COVID-19 Impact On Medical Device …

WebThe COVID-19 health crisis has had a large impact on a plethora of sectors, with the medical device industry appearing as no exception. Many companies within the …

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Medical Devices, Medicinal Substances – and Memorex

WebThe regulatory requirements for drug+device combination products can be daunting, and compliance is a time-consuming and expensive undertaking. But the …

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Blog Medical Device Industry News, Updates, and Resources

WebPublic Health Emergency Expiring: What Will Happen to EUA's? The COVID-19 pandemic has had a profou Why FDA’s Cybersecurity Draft Guidance is a Controversial Change. …

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Fang Consulting Is Your Company’s Medical Device Consulting Firm

WebSince 1999, Fang Consulting, Ltd. has provided regulatory affairs and quality system consulting to a wide range of clients, from the largest medical device manufacturers in …

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Understanding The Transition From MDD To MDR Fang Consulting

WebThe medical device industry is set to fully implement the much-anticipated EU Medical Device Regulation (MDR) at the end of May 2021, after a year-long delay, and …

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Emergency Use Authorization + How To Proceed Fang Consulting

WebThe decision to allow the use of EUAs is made by the Secretary of Health and Human Services (HHS) based on input from the National Institutes of Health (NIH) and …

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Medical Device Consulting Firm Meet Our Team

WebWhen the company was started back in 1999, we knew we had to grab a domain name. Unfortunately, all the typical names were already taken. In a moment of desperation, our …

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Emergency Use Authorization EUA Consulting

WebOver 1,400 previously unapproved medical products have been granted emergency use authorization by the FDA since March 2020 (source: FDA). Conversely, the agency has …

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Why You're Better Off With A 510(k) After COVID-Era EUA …

WebApril 24, 2020 – FDA amends the EUA, removing surgical masks, which require a 510 (k) per 21 CFR 878. May 2020 – FDA revises its Enforcement Policy from March, …

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Is Your Product A Medical Device

WebManufacturers need to align their processes and documentation with these regulations, so knowing whether a product qualifies as a medical device is an important …

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How Do I Know if My Software is a Medical Device

WebMore simply put, the classification of software as a medical device depends on its intended use. If a manufacturer includes a clear medical purpose in the intended …

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Canada Medical Device Consulting Services Fang Consulting

WebBeginning June 23, 2021, Health Canada now requires manufacturers and importers to notify HC of incidents (i.e., recalls, reassessments, suspensions of authorization) in …

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Fang Consulting Medical Device Consulting Services

WebSupplying devoted specialists. Fang Consulting’s all-encompassing services manage all the tasks and labor associated with medical device regulatory submissions, quality systems …

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Who We Serve Offering Medical Device Consulting

WebWHO WE SERVE. We proudly serve companies from. around the world, including 10 of the top. 15 globally ranked medical device. companies of 2022. We are flexible to the

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Quality Management Medical Device QMS Consulting

WebThe team at Fang Consulting has over forty years of combined experience in developing and executing all aspects of a robust quality management system, including conformity …

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What To Know About De Novo Submissions + FDA Guidelines

WebA new classification regulation for the device type is established and permits the device to serve as a predicate device for future 510 (k) submissions. For class II …

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