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Learn What Quality Trends to Watch for in 2021

January 19, 2021 By MassDevice Leave a Comment

2020 was a year of disruption for the industry, but the need to ensure a consistent and high level of quality across the product life cycle hasn’t changed. Read “Shaping the Next Normal for Quality and Compliance” to see what the future holds and how you can utilize new trends to master change at your […]

Filed Under: Whitepapers

Leading Medical UX Trends

January 14, 2021 By MassDevice Leave a Comment

A great way to stay competitive is to innovate with UX Design. There are 7 trends we’re seeing in the medical and life sciences industry that can help your business continue to grow and stay ahead. Virtual healthcare, artificial intelligence and predictive analytics continue to grow, but other trends are emerging as well. Check out […]

Filed Under: Whitepapers

Modernizing Clinical Research: Keeping Pace with Medical Device & Diagnostics Innovation

October 15, 2020 By MassDevice

By: Kevin Liang, Senior Director Strategy, Veeva Medical Device & Diagnostics  Clinical studies are the foundation of successful development of device and diagnostic products. Studies are also complex, from site selection and subject enrollment, to study monitoring, and data management. This year, on top of the usual challenges, COVID-19 brought many clinical studies to a […]

Filed Under: Sponsored Content

Quality System Metrics That Matter

September 11, 2020 By MassDevice

Without effective quality management, it’s impossible to take full advantage of the advanced technology driving the industry today. Read “Quality System Metrics That Matter” to see the exciting results other quality organizations have experienced with MasterControl’s quality solutions and the impact you can expect if you make the switch. If you have questions ~ or […]

Filed Under: Whitepapers

US FDA extends UDI deadlines for low-risk medical devices

July 10, 2020 By MassDevice

By Stewart Eisenhart, Emergo Group Final guidance from the US Food and Drug Administration pushes back enforcement deadlines for certain Unique Device Identification (UDI) requirements for Class I and unclassified medical devices due partially to the agency’s coronavirus pandemic-related priorities. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]

Filed Under: Blog, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Emergo Group, FDA

Medtronic seeks to boost surgical robotics play with Digital Surgery acquisition

February 13, 2020 By MassDevice

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 […]

Filed Under: Business/Financial News, Digital Health, Featured, Mergers & Acquisitions, News Well, Robotics, Surgical Tagged With: Digital Surgery, Medtronic, robot-assisted, Robotic Surgery

How to Successfully Manage Compliance for EU MDR

November 20, 2019 By MassDevice

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 […]

Filed Under: Whitepapers

RAPS meeting highlights medical device regulatory challenges

October 16, 2019 By MassDevice

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 […]

Filed Under: Blog Tagged With: Emergo Group

FDA updates telehealth and digital products guidance for medical device qualifications

October 15, 2019 By MassDevice

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 […]

Filed Under: Blog Tagged With: Emergo Group

FDA revokes voluntary malfunction reporting for some medical devices

October 11, 2019 By MassDevice

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 […]

Filed Under: Blog, Food & Drug Administration (FDA) Tagged With: Registrar Corp.

TÜV Rheinland becomes fifth designated Notified Body under EU MDR

October 4, 2019 By MassDevice

By Stewart Eisenhart, Emergo Group Germany’s TÜV Rheinland has received designation to issue CE Mark certificates under the European Medical Devices Regulation (MDR), raising the total number of Notified Bodies with MDR designation to five. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]

Filed Under: Blog Tagged With: Emergo Group

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