Emmainternational.com

A History of Reproductive Health

WebAs a proud women-owned business, EMMA International has helped bring safe and effective women’s health products to the market. If you are in need of quality …

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URL: https://emmainternational.com/a-history-of-reproductive-health/

Magnesium and High Blood Pressure

WebThe Food and Drug Administration (FDA) recently debuted a new eligible health claim for magnesium. In early January 2022, the FDA ruled that the current data …

Category: Food Go Health

FDA's Digital Health Center of Excellence Platform (DHCoE)

WebSuch a platform is the Digital Health Center of Excellence (DHCoE) which is designed and governed by the FDA. Launched in September 2020, this platform is …

Category: Health Go Health

FDA's role in public health

WebEMMA International plays a role in protecting public health by working alongside life science firms to safely bring their product to market and ensuring …

Category: Health Go Health

Applications of Robotics in Healthcare: A Comprehensive Guide

WebExoskeletons are robots that are utilized in recoveries, and sometimes in surgeries. Care Robots provide support to elderly or disabled patients, assist healthcare …

Category: Health Go Health

ISO 13485:2016 Updates for Medical Devices

WebISO 13485 is an International Organization for Standardization (ISO) standard originally developed in the 1990’s, that consists of requirements for a Quality …

Category: Health Go Health

FDA Fundamentals: Understanding the Different FDA Centers

WebErrored submissions typically lead to large delays and end up costing more. If you need help understanding the regulatory pathways and which FDA organization will …

Category: Health Go Health

Health Canada’s Special Access Program for Medical Devices

WebThere are many such programs available by several regulatory authorities to help protect patient health. To know more about this program or any other Health …

Category: Health Go Health

Health Canada Requirements for Face Shields

WebHealth Canada released a new notification on requirements for companies intending to manufacture face shields during the pandemic. Face shields are considered …

Category: Health Go Health

QFD for Design Controls in Medical Devices

WebThis set of sub requirements is known as Design Controls. In this paper, the history and evolution of quality systems and their application to medical devices will be …

Category: Medical Go Health

Navigating Risk Management in the Pharmaceutical Industry

WebEMMA International can support developing robust risk management programs for your organization. Call us at 248-987-4497 or email …

Category: Health Go Health

FDA Authorized AI-Based Cardiac Ultrasound Software

WebThis is the story of Caption Guidance, the world’s first and only FDA-granted AI-guided cardiac ultrasound software. Built by the California-based Caption Health, the …

Category: Health Go Health

GMP Inspections by Health Canada

WebWe are closely monitoring the regulatory landscape with Health Canada and will keep you posted for any new developments related to medical devices and drugs …

Category: Medical Go Health

Is Your Mobile App a Medical Device

WebWe can help you determine if your app is a medical device and if it is, our regulatory and software experts can guide you step-by-step through the FDA regulatory …

Category: Medical Go Health

Using QFD for Medical Device Development

WebEMMA International can help you optimize your QMS and processes to ensure operational excellence and compliance. Call us at 248-987-4497 or email …

Category: Health Go Health

The Importance of Women in MedTech

WebWe work with incredible women pioneers, some running their own start-ups, and some working with industry giants. EMMA International provides full-circle solutions …

Category: Health Go Health

FDA Regulation of Complementary and Alternative Medicine

WebThe National Center for Complementary and Alternative Medicine (‘ NCCAM ’) is a center within National Institutes of Health. NCCAM defines CAM as “a group of …

Category: Medicine Go Health

Material Science in MedTech

WebIf you need help with any quality, regulatory, or compliance aspect of your product, EMMA International’s team of experts has you covered. Contact us at 248-987 …

Category: Health Go Health

Applications of Augmented Reality in Medical Devices

WebExamples of AR devices cleared through 510 (k)’s include Augmedics surgery guidance Xvision headset, Echo Pixel’s holographic image-producing True 3D …

Category: Health Go Health