Respirators And Barrier Materials By Sarah Smit, Senior Lab Operations Manager and Janelle Bentz, Study Director III Coronavirus The new strain of coronavirus originating in Wuhan, Hubei Province, China has raised new concerns. This virus is similar to the SARS coronavirus and can cause mild to severe respiratory illness. The virus spreads through droplet transmission. […]
Medtronic seeks to boost surgical robotics play with Digital Surgery acquisition
Medtronic (NYSE:MDT) announced today that it has acquired Digital Surgery (London), a privately-held pioneer in surgical artificial intelligence, data and analytics, and digital education and training. Financial terms of the deal were not disclosed. Medtronic said the purchase will strengthen its robot-assisted surgical platform and its broader portfolio. The medical device giant is making a big play […]
Emergo by UL launches 510(k) Builder for streamlined US FDA medical device submissions
Emergo by UL, a global medical device and healthcare technology consultancy, has rolled out 510(k) Builder, a new subscription-based software tool to simplify and streamline medical device manufacturers’ FDA 510(k) submissions in order to obtain faster US market access. Available through Emergo by UL’s Regulatory Affairs Management Suite (RAMS) automated medical device registration and compliance […]
How Digitization Can Help Life Sciences Manufacturers Amplify Lean Principles
By Dave Edwards, Executive Vice President, MasterControl Life sciences manufacturing in 2019 is a dynamic, immensely competitive space in which new markets, ever-changing regulations and exponentially evolving technologies require the C-suite to look for ways to reduce overhead and create greater efficiencies on the shop floor. This imperative means looking for opportunities to improve levels […]
How to Successfully Manage Compliance for EU MDR
As the May 2020 deadline approaches, manufacturers and suppliers are forced to comply or be faced with major implications on their business. The following report outlines a path to compliance and how to: Identify if your company is on course for compliance Manage the 11 new label elements on a global scale Overcome the challenges […]
Lean Product Launch: 3 Ways 3P Events can Boost Efficiency and Speed to Market
By Todd Clark, Program Manager, Viant Get a diverse group of smart people in a room and present them with a challenge. Add brainstorming and collaboration. At the end of the day, the best ideas rise to the top and breakthrough concepts emerge. That’s the magic of a Lean Production Preparation Process (3P) event. For […]
Is your user experience as good as your technology?
By Jesse Darley, Director of Mechanical Engineering & Principal, Delve No doubt, you are passionate about the impact medical devices have on the lives of the patients that need them. In many cases, devices save lives. In more cases, they extend or improve lives. At the core of most devices is a technology that solves […]
3 Clinical Trends Shaping the Medical Device Space in 2019
By Mike Rigert, Staff Writer, MasterControl Perhaps no other sector of the life sciences is experiencing as much growth, transformation and opportunity as the medical device industry. Globally, the medtech arena is expected to grow every year by more than 5 percent, with annual sales worldwide reaching $800 billion by 2030, according to KPMG.(1) In […]
RAPS meeting highlights medical device regulatory challenges
By James Keller, Emergo Group That was the tagline for the 2019 Regulatory Affairs Professionals Society (RAPS) Convergence meeting in Philadelphia this September. As a first-time attendee of RAPS convergence, I could relate. However, for me, and I think for many of the other RAPS attendees, it was like drinking from a fire hose while […]
FDA updates telehealth and digital products guidance for medical device qualifications
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has updated and finalized guidance to determine which mobile medical applications fall under medical device oversight requirements based on their functions. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do […]
FDA revokes voluntary malfunction reporting for some medical devices
By Marco Theobald, Registrar Corp. The U.S. Food and Drug Administration (FDA) recently updated the Voluntary Malfunction Summary Reporting (VMSR) program eligibility status of several medical device product codes. Some previously eligible devices are now ineligible for VMSR, meaning manufacturers must now submit standard individual Medical Device Reports (MDRs) for the newly ineligible products. FDA […]
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