• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    Axonics Buys Contura to Expand to Stress Urinary Incontinence

    Nurx Appoints Chief Medical Officer

    Median Technologies, UC San Diego to Partner on AI-Based Medical Imaging Technology

    Novel Heart Failure Treatment Technology Scores Positive Trial Results

    New COVID-19 Saliva Test Also Can Detect Variants and Flu Viruses
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Rethink Your Medtech ASC Strategy, Part 1

    Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

    Tips for Reigniting Your MDR/IVDR Preparation

    Three Major Innovation Opportunities for Biomedical Textiles

    Use Vertical Integration to Increase Productivity, Drive Innovation
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Medicoil

    Forefront Medical Technology

    PTI Engineered Plastics Inc.

    Medbio LLC

    Spectrum Plastics Group
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Grant Funding Works and How It Can Help

    Refurbished Medical Equipment Testing and Certification Under the NEC

    Taking the First Step with Metal Components

    4 Trends Driving Medical Manufacturing in 2021

    Pioneering AI Solutions to Reinforce Healthcare Services
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    FUTEK Advanced Sensor Technology Inc.

    Medicoil

    Concise Engineering

    K-Tube Technologies

    maxon
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    Galen Data Awarded ISO 13485:2016

    Certification positions company’s cloud-based connected medical platform solution for growth.

    Galen Data Awarded ISO 13485:2016
    Related CONTENT
    • AWAK's Wearable Dialysis System Wins Breakthrough Device Designation
    • FDA's New Actions Concerning the Digital Health Pre-Cert Pilot Program
    • Device to Objectively Assess Pressure Ulcer Risk Wins De Novo Clearance
    • Olympus Fined $85M in Endoscope Case; Former Executive Faces Jail Time
    • Mike on Medtech: Holiday Wish List, Part 1
    Galen Data01.16.19
    Houston-based Galen Data has announced that it has reached a key certification milestone for its cloud-based platform solution for connected medical devices.
     
    The two-year-old company was awarded the ISO 13485:2016 certification following the successful completion of its quality management system audit by global certification firm ECM in late November 2018. The audit ensures compliance with the latest version of the internationally recognized ISO standard. 
     
    “The ISO 13485:2016 certification is a critical milestone in Galen Data’s mission to provide cloud-based medical device connectivity,” said Chris Dupont, CEO of Galen Data. “Medical device makers are turning to us for a cost-effective alternative to building their own connectivity platform. Now they have the added confidence that our cloud-based solution adheres to the highest industry standard for connected medical devices.”
     
    ISO 13485:2016 is a stand-alone quality management system (QMS) standard that includes formal processes for design and change controls, traceability, risk management, verification and validation testing, and regulatory actions, which are relevant to the medical device industry.
     
    It supports medical device manufacturers and helps ensure consistent design, development, production, installation, and delivery of medical devices and software that are safe for their intended purpose.
     
    “This milestone helps to further strengthen Galen Data’s position in the connected medical device market and demonstrates our commitment to regulatory compliance, said Abbas Dhilawala, CTO of Galen Data. “Manufacturers can benefit from a third-party partner like Galen Data who have built their platform under industry standards and are compliant to FDA, HIPAA and CE Mark requirements.”
     
    Building the connectivity infrastructure and meeting regulations can potentially increase costs and add unnecessary risks for companies who lack the required FDA knowledge, technical expertise, and internal resources. Galen Data’s managed solution handles all operational aspects including security, privacy, monitoring, and backups.
    Related Searches
    • company
    • market
    • quality
    • medical
    Related Knowledge Center
    • Digital Health
    • Software & IT
    Suggested For You
    AWAK AWAK's Wearable Dialysis System Wins Breakthrough Device Designation
    FDA FDA's New Actions Concerning the Digital Health Pre-Cert Pilot Program
    Device to Objectively Assess Pressure Ulcer Risk Wins De Novo Clearance Device to Objectively Assess Pressure Ulcer Risk Wins De Novo Clearance
    Olympus Fined $85M in Endoscope Case; Former Executive Faces Jail Time Olympus Fined $85M in Endoscope Case; Former Executive Faces Jail Time
    Mike on Medtech: Holiday Wish List, Part 1 Mike on Medtech: Holiday Wish List, Part 1
    FDA Green Lights First Test to Help Detect Cytomegalovirus in Newborns FDA Green Lights First Test to Help Detect Cytomegalovirus in Newborns
    New Efforts to Strengthen FDA’s Expanded Access Program New Efforts to Strengthen FDA’s Expanded Access Program
     Sensera Achieves ISO 13485 Quality Certification Sensera Achieves ISO 13485 Quality Certification
    Zingbox Identifies New Trend in Cyber Attacks Targeting Connected Medical IoT Devices Zingbox Identifies New Trend in Cyber Attacks Targeting Connected Medical IoT Devices
    FDA and DHS Begin Partnership to Address Medical Device Cybersecurity Threats FDA and DHS Begin Partnership to Address Medical Device Cybersecurity Threats
    FDA Approves New DNA-Based Test to Determine Blood Compatibility FDA Approves New DNA-Based Test to Determine Blood Compatibility
    Bose Bose's Self-Fitting, User-Controlled Hearing Aid Wins FDA Nod
    Intertek Accredited for End-to-End Evaluation of Implantable, Non-Implantable Medical Devices Intertek Accredited for End-to-End Evaluation of Implantable, Non-Implantable Medical Devices
    FDA Awards Five Grants to Advance Pediatric Device Developments FDA Awards Five Grants to Advance Pediatric Device Developments
    Driving Toward Custom Electronics Driving Toward Custom Electronics

    Related Breaking News

    • Digital Health
      Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably

      Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably

      The FDA’s five-part action plan is expected to drive the surge.
      Michael Barbella, Managing Editor 02.26.21

    • Digital Health
      Terumo to Purchase Predictive Analytics Firm Health Outcomes Sciences

      Terumo to Purchase Predictive Analytics Firm Health Outcomes Sciences

      Will enable personalized, predictive insights at the point of care.
      Sam Brusco, Associate Editor 02.24.21

    • Digital Health | Patient Monitoring
      Masimo Launches Tool to Support Reopening Schools, Businesses

      Masimo Launches Tool to Support Reopening Schools, Businesses

      Masimo SafetyNet-OPEN helps screen, trace, and manage users as they face COVID-19 and other infectious illnesses.
      Sam Brusco, Associate Editor 02.16.21


    • Digital Health | Patient Monitoring | Software & IT
      FDA OKs CLEW

      FDA OKs CLEW's AI-Based ICU Predictive Analytics Tech

      CLEWICU predicts hemodynamic instability in adult patients.
      Sam Brusco, Associate Editor 02.04.21

    • Digital Health | Patient Monitoring
      Philips Inks Connected Care Solutions Deal with 28-Hospital Dutch SAZ Group

      Philips Inks Connected Care Solutions Deal with 28-Hospital Dutch SAZ Group

      Different SAZ hospitals will start with Philips solutions for patient monitoring and self-management.
      Sam Brusco, Associate Editor 02.04.21

    • Diagnostics | Digital Health | Software & IT
      Hologic, Google Cloud Begin Collaboration on Next-Gen Dx Tech

      Hologic, Google Cloud Begin Collaboration on Next-Gen Dx Tech

      Enhancing AI and machine learning for breakthrough results in cervical cancer screening.
      Sam Brusco, Associate Editor 02.02.21


    • Digital Health | Software & IT
      Philips Buys Capsule Technologies in $635M Deal

      Philips Buys Capsule Technologies in $635M Deal

      Capsule offers vendor-neutral Medical Device Information Platform with an SaaS business model.
      GlobeNewswire 01.19.21

    • Digital Health | Software & IT
      FDA Releases Artificial Intelligence, Machine Learning Action Plan

      FDA Releases Artificial Intelligence, Machine Learning Action Plan

      Outlines FDA’s next steps toward furthering oversight for AI/ML-based "software as a medical device."
      U.S. Food and Drug Administration 01.13.21

    • Chronic Disease | Digital Health | Patient Monitoring
      Teladoc Health, Dexcom Launch CGM Tech, Personalized Insights for Type 2 Diabetes

      Teladoc Health, Dexcom Launch CGM Tech, Personalized Insights for Type 2 Diabetes

      CGM-powered insights offer complete health profile, recommendations that support ongoing diabetes management.
      GlobeNewswire 01.13.21


    • Software & IT
      Censis Technologies, Cantel Medical Partner on Endoscope Reprocessing Software Solution

      Censis Technologies, Cantel Medical Partner on Endoscope Reprocessing Software Solution

      Companies developing an enhanced integrated workflow solution designed to provide superior infection prevention and practice optimization.
      Business Wire 01.07.21

    • Digital Health
      Digital Medicine Key to Revolutionizing Patient Health Outcomes

      Digital Medicine Key to Revolutionizing Patient Health Outcomes

      The global COVID-19 pandemic emphasized the need for digital medicine in improving health.
      GlobalData 12.14.20

    • Digital Health
      New Software Supports Increased Demand for Personalized Medical Devices

      New Software Supports Increased Demand for Personalized Medical Devices

      SurgiCase streamlines collaboration between medical device companies and clinicians.
      Materialise N.V. 12.10.20


    • Patient Monitoring | Software & IT
      AI Metrics

      AI Metrics' Liver Imaging Software Earns FDA Nod

      Early-stage startup approved for low-cost, low-risk, non-invasive procedures for chronic liver disease patients.
      University of Alabama at Birmingham 12.09.20

    • Digital Health
      FDA OKs AireHealth

      FDA OKs AireHealth's VitalMed Connected Nebulizer

      Bluetooth-enabled, portable nebulizer will help track symptoms and support medication adherence.
      Business Wire 12.09.20

    • Diagnostics | Software & IT
      FDA OKs Hologic

      FDA OKs Hologic's Genius AI Breast Cancer Detection Software

      New deep-learning algorithm helps radiologists detect breast cancers in their early stages.
      Business Wire 12.01.20


    Trending
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • 7 Considerations For Designing Medical Device Mechanisms
    • Common Issues And Their Solutions In Health Application Development
    Breaking News
    • Axonics Buys Contura to Expand to Stress Urinary Incontinence
    • Nurx Appoints Chief Medical Officer
    • Median Technologies, UC San Diego to Partner on AI-Based Medical Imaging Technology
    • Novel Heart Failure Treatment Technology Scores Positive Trial Results
    • New COVID-19 Saliva Test Also Can Detect Variants and Flu Viruses
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • Seeking a Revolution in Clinical Care Through AI
    • Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit
    • Addition by Subtraction: The Latest of Machining for Medtech
    • Innovation Incubators: An R&D Roundtable
    • Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Martin Bauer Group Acquires Majority Stake in Beverage Company Power Brands
    Gencor Announces Positive Results in VeriSperse Bioavailability Study
    PanTheryx Inc. Acquires TruBiotics Brand from Bayer HealthCare LLC
    Coatings World

    Latest Breaking News From Coatings World

    Mule-Hide Products Co. Promotes Steven Litaker to Territory Manager
    Terra Firma, Wanhua Announce New Distribution Partnership
    Gelest CEO Elected to National Academy of Engineering
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Axonics Buys Contura to Expand to Stress Urinary Incontinence
    Nurx Appoints Chief Medical Officer
    Median Technologies, UC San Diego to Partner on AI-Based Medical Imaging Technology
    Contract Pharma

    Latest Breaking News From Contract Pharma

    J&J’s Single-Dose COVID-19 Vax Issued EUA
    Icon to Acquire PRA Health Sciences
    Phlow Corp. and USP Form Alliance
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Universal Engraving Announces New President
    Raw Sugar Living Expands to Target with New Collection
    Supporting Female Beauty Brand Founders on International Women's Day
    Happi

    Latest Breaking News From Happi

    ACI and CBC Launch Webpage About ‘Quats’
    L’Occitane Launches Hand Cream Inspired by Women
    Kiehl’s Partners with Gyrl Wonder
    Ink World

    Latest Breaking News From Ink World

    Access Direct Mail Doubles Revenue with SCREEN's Truepress Jet520HD
    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Edale names SMAG Graphique distributor in France
    TLMI analyzes pandemic's effect on label industry in new report
    UEI names Ross Hutchison president
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    U.S. Nonwovens Rebrands as Radienz Living
    What You’re Reading on Nonwovens-Industry.com
    Texas Medical Technology Partners with My Protect Kit
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Pandemic Pain: NuVasive's 2020 Sales Fall 10 Percent
    Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System
    Kaia Health Unveils Next-Gen Complete MSK Care Solutions
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login