• 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
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    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
    Regulatory
    Financial/Business
    Top News
    BMP Medical Expands Sterling, Massachusetts Facility

    Abbott's Proclaim XR SCS OK'ed for Diabetic Neuropathy

    Environmental Sustainability Becoming Increasingly Important to Medtech Industry

    Duane DiFranco Joins Harvard MedTech’s Medical Advisory Board

    Lionel Bonte Named President of Mativ’s Healthcare and Wellness Business Unit
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Reflections on 2022 and What’s Ahead for Medtech: MPO Sounding Board

    3 Ways to Prepare for ISO 13485/Part 820 Harmonization

    A New Home for Theranos' Elizabeth Holmes?

    Health Cost Drivers for Large Employers

    Braving Change: Facing Fears in the Midst of Major Transitions
    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
    LEMO USA Inc.

    Forefront Medical Technology

    Medbio LLC

    Halkey-Roberts Corporation

    Arthur G. Russell Co. Inc., The
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Artificial Intelligence Can Combat Key Issues Impacting Healthcare

    Why Advanced Sensors Are Crucial Within Medical Pumps

    How Artificial Intelligence Could Help Prevent 80% of Chronic Diseases

    4 Ways to Use Injection Molding in Medical Device Manufacturing

    Telemedicine and Connectivity to Drive Material Innovation in the Near Future
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    LEMO USA Inc.

    Forefront Medical Technology

    Medbio LLC

    Halkey-Roberts Corporation

    Arthur G. Russell Co. Inc., The
    • 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
    • eBook
    • Resources
    • Podcasts
    • 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
    Online Exclusives

    Three Reasons Automation and Training Are Essential in Your MDQMS

    Having the proper tools in place to ensure all training activities are occurring when and how they should is critical to quality.

    Three Reasons Automation and Training Are Essential in Your MDQMS
    Related CONTENT
    • Providien
    • RJG
    • Zeus
    • NTK Cutting Tools USA
    • Nissha Medical Technologies
    Jon Speer, Founder, Greenlight Guru03.15.21
    Error is the bane of medical device quality. Even minor mistakes can lead to serious flaws in products, potentially harming end users. The right training can greatly reduce the risk of making these kinds of errors, but when the quality system managing training is cumbersome and disconnected, it can do little to solve the problem at hand.
     
    Training in the medical device industry often relies heavily on legacy tools, paper-pushing, and checking boxes, with little attention paid toward its downstream effects on quality. Trying to track training activities and records in this type of static system is burdensome and obscures valuable insights from being gained by even the most effective companies.
     
    Yet, training is an integral part of your business. It not only will help you meet compliance requirements but also factors into overall product quality. Companies are developing their medical device quality management systems (MDQMS) to demonstrate closed-loop traceability of every system process, and training must be included in that effort. To help facilitate this, manual processes and legacy tools should be set aside in favor of quality automation tools. Following are three reasons why training and automation are essential if companies want to reduce risk and improve patient outcomes.
     
    1. Make the Training Process Easier
    Separating training from the rest of your quality system processes adds an unnecessary layer between trainers and trainees. If a manager has to manually assign training activities, set due dates, and update the completion status for every trainee, then there’s a much higher likelihood that something will slip through the cracks. When the training activities themselves can be a deciding factor of whether or not your product succeeds, that’s not a chance worth taking.
     
    A purpose-built MDQMS can easily incorporate the small, but vital, pieces of the training process into a system that works for you. For example, managers can assign training activities with a few clicks and then rely on automated processes to notify trainees and track their progress. Trainees can then sign into a dedicated workflow within the software platform to view personalized dashboards, where they can find these assignments or outstanding training activities. When a training task is completed, managers can assess competence from the document level or by an individual or group. This eliminates the disconnect between people and information, streamlining and improving the overall training management process while simplifying compliance needs.
     
    2. Improve Training Activity Development
    How can you tell if your training activities are effective? With a spreadsheet or manual quality system, it’s much tougher to map the quality needs that your training intends to address back to your training activities and processes. And if those needs change, it’s even more challenging.
     
    On a functional level, a modern MDQMS with an integrated training management workflow can help managers track the effectiveness of a training program. Each training activity can be set up to require a trainer sign-off, attesting competency of an employee, specifically for regulatory purposes. These secure electronic signatures are compliant with 21 CFR Part 11 and offer objective evidence that adequate training is being conducted.
     
    Because all training is integrated within a closed-loop quality system, you also gain insight into connected processes from your overall quality ecosystem. If a subsystem of that ecosystem is faltering, training data can be used to shed light on creative solutions to adjust training activities in order to mitigate immediate and long-term problems. Visibility into the status of training activities increases overall efficiency and efficacy while ensuring you’re meeting the necessary quality standards.
     
    3. Prepare Proactively for Audits
    We’re seeing an increasing focus on training requirements during audits and inspections, meaning proper training and supporting documentation is no longer a nice-to-have, but a must-have for passing an audit. Still, training managers continue to struggle when using disparate systems to document and track who’s been trained on what. Without easy-to-navigate training records, you can be left exposed come audit time. For example, if your team implemented new processes or updated existing procedures, would you know who’s been properly trained and when that training took place? Is your only record a calendar event buried in months of other meetings?
     
    A modern MDQMS leverages automation and traceability to produce and maintain meaningful training records. Instead of scouring your calendar for a training activity’s invite, your quality system can auto-generate logs, store supporting evidence needed by regulators, and generate details of trainees’ records without a manager lifting his or her finger. This streamlined system provides the much-needed assurance through an audit trail that confirms training occurred when it was supposed to and personnel have the competency required to do their job effectively. This valuable training management solution has helped 95 percent of MDQMS users feel confident they could pass an unannounced audit today, according to our 2021 State of the Medical Device Industry report.
     
    High quality outcomes demand high quality training. To reduce the risk of errors and increase efficiency and efficacy, having the ability to incorporate training activities and records into your MDQMS has never been more important. These essential quality system functions will save you time and money while improving the quality, safety, and effectiveness of your medical device.
     

    Jon Speer is the founder at Greenlight Guru, a medical device quality management MDQMS software. He is a medical device guru with over 22 years of industry experience. Speer knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to achieve True Quality.
    Related Searches
    • Software & IT
    Related Knowledge Center
    • Software & IT
    Suggested For You
    Providien Providien
    RJG RJG
    Zeus Zeus
    NTK Cutting Tools USA NTK Cutting Tools USA
    Nissha Medical Technologies Nissha Medical Technologies
    JK Medirise-Disposable Medical Device Company JK Medirise-Disposable Medical Device Company
    DDL Inc. DDL Inc.
    sfm medical devices GmbH sfm medical devices GmbH
    Simbex Simbex
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    High Tech Turning Co. Inc. High Tech Turning Co. Inc.
    Breakthrough Device Designation Granted for New Neuromodulation Platform Breakthrough Device Designation Granted for New Neuromodulation Platform
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    Accu-Tube Appoints Matthew Haddle as CEO Accu-Tube Appoints Matthew Haddle as CEO
    First CellFX Procedure Performed in Canada First CellFX Procedure Performed in Canada

    Related Buyers Guide Companies

    • Providien

      Providien

      ...
      Bonalyn Boyd, Marketing Manager 11.30.22

    • RJG

      RJG

      ...
      Kara Eskeli 11.21.22

    • Zeus

      Zeus

      ...
      Laura Bright, Ad Manager 11.18.22


    • NTK Cutting Tools USA

      ...
      Melissa Singher, Senior Product Coordinator 11.18.22

    • Nissha Medical Technologies

      ...
      Amy Jeary, Market Development Manager 11.18.22

    Loading, Please Wait..

    Trending
    • Study: Catheter Ablation Significantly Lowers Dementia Risk In AFib Patients
    • Tandem Diabetes Completes Deal For AMF Medical
    • BMP Medical Expands Sterling, Massachusetts Facility
    • Abbott's Proclaim XR SCS OK'ed For Diabetic Neuropathy
    • The Future Of Biomedical Engineering Advancements
    Breaking News
    • BMP Medical Expands Sterling, Massachusetts Facility
    • Abbott's Proclaim XR SCS OK'ed for Diabetic Neuropathy
    • Environmental Sustainability Becoming Increasingly Important to Medtech Industry
    • Duane DiFranco Joins Harvard MedTech’s Medical Advisory Board
    • Lionel Bonte Named President of Mativ’s Healthcare and Wellness Business Unit
    View Breaking News >
    CURRENT ISSUE

    November 2022

    • MPO's 2022 Year in Review
    • Fine Print: A Discourse on Additive Manufacturing
    • Grab and Go: Examining the Thrombectomy Device Market
    • 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

    Vitamin D Supplementation Reduces Risk of Dynapenia
    Sustained-Release Caffeine Ingredient Offers Mood, Performance Benefits
    Multi-Strain Probiotic Improves Self-Reported Mood, Sleep, Serotonin Levels
    Coatings World

    Latest Breaking News From Coatings World

    Epoxytec Announces New Website Launch
    Paints and Coatings Market Worth $212B by 2026: MarketsandMarkets
    Axalta Releases Fourth Quarter and Full Year 2022 Results
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    BMP Medical Expands Sterling, Massachusetts Facility
    Abbott's Proclaim XR SCS OK'ed for Diabetic Neuropathy
    Environmental Sustainability Becoming Increasingly Important to Medtech Industry
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Pasithea Signs CMC Development and Manufacturing Agreement
    Experic Expands Analytical Capabilities and Facilities
    List Labs Expands Manufacturing Capacity
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Haircare Brand Uncle Funky’s Daughter Announces Retail Expansion
    TRESemmé Introduces New Pro Infusion Collection
    Walgreens Boots Alliance Shares 2022 ESG Report
    Happi

    Latest Breaking News From Happi

    KimChi Beauty Launches Spinning Hearts Love 02 Ahead of Valentine’s Day
    Dark & Lovely Names Actress Meagan Good Brand Ambassador
    Natural Household Care Company Tru Earth Adds Dishwasher Detergent Tablets
    Ink World

    Latest Breaking News From Ink World

    Xerox Releases 4Q, Full-Year 2022 Results
    Electronics For Imaging Names Frank Pennisi as CEO
    Fiery to Separate from EFI, Remain Wholly-Owned by Siris
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    EFI appoints Frank Pennisi CEO, Fiery now an independent business
    Bobst boosts senior sales team with Keith Nagle
    Penmar Industries adds Screen Truepress Jet L350UV SAI digital press
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Essity’s Sales Grow
    Thinx to Pay up to $5 million to Settle Class Action Suit
    Typar Highlighting New Building Innovations
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Orthofix Launches the Mariner Deformity System
    Tyber Medical Hires 2 New Execs
    Miach Ortho Raises $40M in Series B Funding
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Smart Devices with Privacy Focus Have More Consumer Appeal
    Siman Group Partners with SML to Unlock Full Retail Potential with RFID
    Brewer Science Presents Optics Integration Solutions at SPIE Photonics West

    Copyright © 2023 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