Medical device design

Strides Made in Additive Manufacturing Drive 3D Printing Medical Devices Market; Relentless Research by Top Players Makes North America Lucrative Region - TMR

Retrieved on: 
Friday, May 29, 2020
Emerging technologies, Industrial design, Industrial processes, Articles, 3D printing, DIY culture, Medical device design, Medical device, Technology, Economic sectors

Cost-efficiency and productivity gains for medical device manufacturers using 3D printing systems and materials will help the market reach new heights.

Key Points: 
  • Cost-efficiency and productivity gains for medical device manufacturers using 3D printing systems and materials will help the market reach new heights.
  • The current valuation of the 3D printing medical devices market stood at US$823.0 million in 2016 and is projected to expand at 17.7% CAGR from 2017 to 2025 (the forecast period).
  • Strategic investments by leading players will help unlock new prospects in the 3D printing medical devices market, note analysts at TMR.
  • Leading segments of the global 3D printing medical device market:
    3D Printing Medical Device Market, by Component

M Squared Associates Providing Pro Bono Consulting Services to Expedite COVID19-Related FDA Applications for Critical Medical Supplies

Retrieved on: 
Wednesday, April 8, 2020
Food and Drug Administration, Health, Emergency Use Authorization, Medical device design, Medical device

FDA has declared the COVID-19 outbreak a public health emergency and implemented an expedited pathway to market authorization for products crucial in addressing this crisis, the Emergency Use Authorization (EUA).

Key Points: 
  • FDA has declared the COVID-19 outbreak a public health emergency and implemented an expedited pathway to market authorization for products crucial in addressing this crisis, the Emergency Use Authorization (EUA).
  • The EUA pathway gives FDA authority to authorize rapid access to unapproved medical devices and diagnostic tests (or unapproved uses of approved devices) for emergency applications where there are no adequate or approved alternatives available.
  • New York City based M Squared Associates (M2), a consulting firm providing regulatory, quality and clinical services to the medical technology industry, has been providing pro bono consulting expertise to innovators and developers who may not be registered medical device manufacturers, but who can help address shortages of supplies needed for the diagnosis, treatment, monitoring and prevention of COVID-19 in the US and globally.
  • M Squared Associates is helping to determine eligibility for the EUA program, assess if a specific product meets the definition of a medical device, and prepare documentation for submission to FDA (or another regulatory body) prior to manufacturing and distribution.

Regulatory Intelligence Report for Medical Devices in the U.S.

Retrieved on: 
Monday, March 2, 2020
Health, Food and Drug Administration, Articles, Pharmaceuticals policy, Medical device, Federal Food, Drug, and Cosmetic Act, Food and Drug Administration Modernization Act, Medical device design

- Insights into the current regulations and comprehensive procedures for the registration, renewal or notification of the medical devices, along with the information on timeline and fee required

Key Points: 
  • - Insights into the current regulations and comprehensive procedures for the registration, renewal or notification of the medical devices, along with the information on timeline and fee required
    - Information on Federal Food, Drug, and Cosmetic Act (the Act) and how it works towards the betterment of society
    The goals of this study were to understand the regulations and requirements of the companies in the US and the foreign companies or establishments planning to manufacture, distribute or market their medical devices in the US.
  • This report provides a brief about the related regulation for registration of the establishments or medical devices along with the classification of the devices.
  • ReportLinker is an award-winning market research solution.
  • Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

Orthofix Announces Support for Continued FDA Class III Designation for Bone Growth Stimulators to Ensure Patient Safety and Therapy Efficacy

Retrieved on: 
Monday, February 24, 2020
Surgery, Medical devices, FDA, Public policy, Government, Healthcare reform, Philanthropy, Biotechnology, Health, Other Policy Issues, Health, Medicine, Food and Drug Administration, Medical device, Electrotherapy, Food law, Federal Food, Drug, and Cosmetic Act, Medical device design

(NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products, announces support for the continued U.S. Food and Drug Administration (FDA) Class III designation for Bone Growth Stimulators to ensure patient safety and therapy efficacy.

Key Points: 
  • (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products, announces support for the continued U.S. Food and Drug Administration (FDA) Class III designation for Bone Growth Stimulators to ensure patient safety and therapy efficacy.
  • Class III devices are subject to the most rigorous pathway to approval for medical devices.
  • FDA may change classification of a device only if the proposed new class has sufficient regulatory controls to provide reasonable assurances of safety and effectiveness.
  • In 2006, FDA convened an advisory panel and ultimately determined, for safety and efficacy reasons, to maintain the Class III status for BGS devices.

Two Day FDA Approval Process for Medical Devices Seminar: Gain an Understanding of the Underlying Legal and Regulatory Requirements - London, United Kingdom - September 16-17, 2019

Retrieved on: 
Wednesday, June 5, 2019
Health, Food and Drug Administration, Medical device, Articles, Pharmaceuticals policy, Pharmaceutical industry, Clinical research, Medical device design

DUBLIN, June 5, 2019 /PRNewswire/ -- The "FDA Approval Process for Medical Devices" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, June 5, 2019 /PRNewswire/ -- The "FDA Approval Process for Medical Devices" conference has been added to ResearchAndMarkets.com's offering.
  • Participants will gain an understanding of the underlying legal and regulatory requirements and the general controls applicable to all devices, including device classification, establishment registration and device listing.
  • Participants will also learn about the pre-submission process, which FDA strongly recommends prior to the initial submission of novel devices to help ensure a successful submission process.
  • Management, legal, medical, marketing and other professionals who are interested in understanding the key principles of the medical device approval process will also benefit in attending.