Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Greenlight Guru updates software to changed ISO standard

March 9, 2020 By Nancy Crotti

greenlight-guru-logoGreenlight Guru today announced new software platform updates to align with the recently updated ISO14971:2019 standard, as well as further enhancements to the change-management capabilities the company debuted in December 2019.

ISO 14971 is the predominant standard for risk management in the medtech industry. Put into effect in December 2019, ISO 14971:2019 is the latest update to the application of risk management for medical devices. It serves to define better key terminology, residual risk identification, and personnel competence, according to the Indianapolis-based company.

“This iteration of the ISO 14971 standard is the first update in nearly 13 years, and offers much-needed clarifications to reflect current best practices,” said Jon Speer, VP of quality assurance and regulatory affairs at Greenlight Guru, in a news release. “The update to our platform not only conforms to the new standard but represents our continued dedication to being the best quality management system for medical device companies.”

Updates to the Greenlight Guru platform reflect changes to align with ISO 14971:2019 as well as several productivity enhancements, including enhanced change-management capabilities intended to assure medtech companies are systematically assessing the impact of changes through built-in change evaluation functionality. The update also introduces group management, which gives companies the flexibility to create and manage different groups of employees based on how their teams or organization are structured.

Related Articles Read More >

Fresenius Medical Care
FDA warns of potential toxic risk from Fresenius hemodialysis machines
Von Mises stress (Mpa)
How to speed through the 60601 drop test with finite element analysis
microscope testing analysis medical devices
3 questions medical device manufacturers should ask before ISO 10993-17 updates
Sommetrics lands ISO 13485 certification

DeviceTalks Weekly.

May 13, 2022
Our Pre-Post-DeviceTalks Boston episode, also MedtronicTalks replay with Gastro CMO Austin Chiang
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech