• 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
    Adding Fabrication Capabilities: Additive Manufacturing for Production Parts

    Delivering the Goods: The Evolving World of Combination Products

    Anxious Undertones: The 2019 Year in Review

    From Art to Science: The Changing Face of Extrusion

    Exact Science: A Micromolding Roundtable
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    FDA OKs World's First Single-Use Duodenoscope

    Dr. Stephen Hahn Confirmed as New FDA Leader

    FDA OKs First Test to Help Screen for Newborn Duchenne Muscular Dystrophy

    MedStar Health and Cleveland Clinic Innovations Awarded Grant

    3M to Sell Drug Delivery Business for $650M
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Adding Fabrication Capabilities: Additive Manufacturing for Production Parts

    Delivering the Goods: The Evolving World of Combination Products

    Anxious Undertones: The 2019 Year in Review

    From Art to Science: The Changing Face of Extrusion

    Exact Science: A Micromolding Roundtable
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    From Genome Sequencing to the World’s First Portable MRI

    An Update on Digital Health

    ‘If You’re Reading This, You Need to Be at This Meeting’

    Five Steps for Succeeding Globally in Medtech

    Unlocking Market Doors with Real-World Evidence
    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
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Accumold

    Zeus

    Carclo Technical Plastics

    RJG Inc.

    Eurofins Medical Device Testing
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    EU's MDR: Irresistible Force Meets Immovable Object

    Ladies First: An Examination of the Women's Health Device Industry

    Localizing Medical Devices

    Sounding Board: Looking Back at 2019 and Gazing at 2020

    Understanding Key Processes for Mixing APIs with Silicone
    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.

    Lyons

    Fusion Biotec Inc.

    DELMIAWORKS (IQMS)

    MicroLumen Inc.
    • 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
    • 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

    DirectMed Parts & Service Receives ISO 13485 Certification for MRI, CT Parts and Service

    The achievement is in addition to the company’s ISO 9001:2015 certification.

    Related CONTENT
    • MPO Summit Conference Program Notebook
    • AMADA MIYACHI AMERICA Receives ISO 9001 Certification
    • LDRA Clears Medical Device Manufacturers’ Path to IEC 62304 Compliance
    • Medtech Mettle: The 2017 Year in Review
    • Enable Injections Awarded ISO 13485:2016 Certification
    Business Wire04.05.18
    DirectMed Parts & Service LLC, a medical imaging parts and service company, has received ISO 13485:2016 certification for its magnetic resonance imaging (MRI) and computed tomography (CT) parts and service. This achievement is in addition to the company’s ISO 9001:2015 certification.
     
    The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of quality management systems. The ISO 13485:2016 Quality Management Standard for Medical Devices represents the requirements for a comprehensive management system for the design and manufacture of medical devices. ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide products that meet customer and applicable statutory and regulatory requirements.
     
    “Achieving ISO certification demonstrates that DirectMed has successfully implemented a quality management system that conforms to the world-wide standard for medical device and medical imaging parts and service,” said Tim Kearney, director of Inventory Management at DirectMed. “The ISO 13485:2016 certification represents an important milestone for our company and reflects our commitment to providing high quality products that meet or exceed customer expectations and comply with regulations.”
     
    Brad de Koning, CEO of DirectMed Parts & Service LLC commented: “This ISO certification is a testament to the high level of performance, quality control and continuous improvement we expect at our company. With an expanding global customer base, this level of rigor is important to ensure our 16,000 imaging products continue to provide reliable and measurable results.”
     
    DirectMed is a source for medical imaging parts and services in the industry. Specializing in CT and MRI parts and service, DirectMed works directly with engineers and service professionals to deliver quality parts to customer sites as quickly as possible, minimizing down time of critical equipment. The company is based in Poway, Calif.
    Related Searches
    • iso 13485
    • company
    • ceo
    • quality management system
    Suggested For You
    Sanmina Becomes First Tier 1 EMS Company to Achieve FDA Registration in India Sanmina Becomes First Tier 1 EMS Company to Achieve FDA Registration in India
    India’s New Medical Devices Rules India’s New Medical Devices Rules
    ISO 13485 2016: Upgrading to the New Edition (Part 1) ISO 13485 2016: Upgrading to the New Edition (Part 1)
    Lantheus Holdings Appoints Three New Board Members Lantheus Holdings Appoints Three New Board Members
    Valeritas Announces V-Go Distribution Agreement in Italy With Movi SpA Valeritas Announces V-Go Distribution Agreement in Italy With Movi SpA
    Five Strategies to Reduce Liability Five Strategies to Reduce Liability
    The Value of (Outside) Evaluation: Outsourcing Testing Services The Value of (Outside) Evaluation: Outsourcing Testing Services
    How an Automated QMS Helps to Keep Up with  Regulatory Changes How an Automated QMS Helps to Keep Up with Regulatory Changes
    Enable Injections Awarded ISO 13485:2016 Certification Enable Injections Awarded ISO 13485:2016 Certification
    Medtech Mettle: The 2017 Year in Review Medtech Mettle: The 2017 Year in Review
    LDRA Clears Medical Device Manufacturers’ Path to IEC 62304 Compliance LDRA Clears Medical Device Manufacturers’ Path to IEC 62304 Compliance
    AMADA MIYACHI AMERICA Receives ISO 9001 Certification AMADA MIYACHI AMERICA Receives ISO 9001 Certification
    MPO Summit Conference Program Notebook MPO Summit Conference Program Notebook

    Related Breaking News

    • Surgical
      FDA OKs World

      FDA OKs World's First Single-Use Duodenoscope

      Boston Scientific's EXALT Model D Duodenoscope eliminates the need for duodenoscope reprocessing and repairs,
      PR Newswire 12.13.19

    • Dr. Stephen Hahn Confirmed as New FDA Leader

      Dr. Stephen Hahn Confirmed as New FDA Leader

      He has never worked in a government position, so his potential FDA agenda is currently unknown.
      Sam Brusco, Associate Editor 12.13.19

    • Diagnostics
      FDA OKs First Test to Help Screen for Newborn Duchenne Muscular Dystrophy

      FDA OKs First Test to Help Screen for Newborn Duchenne Muscular Dystrophy

      PerkinElmer's test measures dried blood samples collected from the prick of a newborn’s heel 24 to 48 hours after birth.
      U.S. Food and Drug Administration 12.13.19


    • Contract Manufacturing | R&D & Design
      MedStar Health and Cleveland Clinic Innovations Awarded Grant

      MedStar Health and Cleveland Clinic Innovations Awarded Grant

      Cool Idea Award from Protolabs spurs innovation.
      Protolabs 12.12.19

    • 3M to Sell Drug Delivery Business for $650M

      3M to Sell Drug Delivery Business for $650M

      The business, which has annual sales of about $380 million, is being sold to an affiliate of Altaris Capital Partners.
      Business Wire 12.12.19

    • Neurological
      First U.S. Patient Implanted With Axonics

      First U.S. Patient Implanted With Axonics' Sacral Neuromodulation System

      The Axonics r-SNM System is approximately the size of a USB stick and is qualified to operate for at least 15 years.
      Businesswire 12.12.19


    • Cardiovascular
      First U.S. Patients Treated With a Minimally Invasive, Forward Flow Heart Pump

      First U.S. Patients Treated With a Minimally Invasive, Forward Flow Heart Pump

      Impella 5.5 with SmartAssist delivers peak flows of greater than six liters per minute.
      Businesswire 12.12.19

    • Digital Health
      New Pocket Ultrasound Scanners Smaller, More Powerful, and More Affordable

      New Pocket Ultrasound Scanners Smaller, More Powerful, and More Affordable

      Easier to use, second-generation ultra portable wireless scanners give doctors a clearer picture of what's going on.
      PR Newswire 12.12.19

    • Digital Health | Software & IT
      15-Year Tele-Critical Care Collabration Yields Significant ICU Improvement Results

      15-Year Tele-Critical Care Collabration Yields Significant ICU Improvement Results

      Florida’s first eICU, powered by Philips telehealth technology, touts reduced mortality rates and hospital stays for the sickest patients.
      GlobeNewswire 12.11.19


    • 3D/Additive Manufacturing | Software & IT
      Prellis Biologics

      Prellis Biologics' New Tool Simplifies Complex Tissue Engineering

      TissueWorkshop generates complex 3D scaffolds that can be printed with any 3D printing system.
      Krause Taylor Associates 12.11.19

    • InspireMD

      InspireMD's CEO Steps Down

      New CEO Marvin Slosman, a life sciences industry veteran, joins InspireMD from Integra LifeSciences.
      GlobeNewswire 12.11.19

    • Celmatix Sues Research Partner 23andMe for $100M

      Celmatix Sues Research Partner 23andMe for $100M

      Celmatix claims breaches of the parties' agreement and tortious interference with efforts to raise capital.
      PR Newswire 12.11.19

    • FDA Cleared New Cochlear Osia 2 System

      FDA Cleared New Cochlear Osia 2 System

      The world’s first active osseointegrated steady-state implant.
      Cochlear 12.11.19

    • Neurological
      FDA Approves First Nasal Rescue Treatment for Frequent Seizure Activity

      FDA Approves First Nasal Rescue Treatment for Frequent Seizure Activity

      Aptar’s Unidose Liquid System can deliver a formulation in an emergency situation quickly and easily and be administered by a non-healthcare professional.
      Business Wire 12.10.19

    • Diagnostics
      Lens-Free Microendoscope Generates High Quality Images

      Lens-Free Microendoscope Generates High Quality Images

      It also doesn't require movement to focus on objects at different depths.
      Johns Hopkins University 12.10.19


    Breaking News
    • FDA OKs World's First Single-Use Duodenoscope
    • Dr. Stephen Hahn Confirmed as New FDA Leader
    • FDA OKs First Test to Help Screen for Newborn Duchenne Muscular Dystrophy
    • MedStar Health and Cleveland Clinic Innovations Awarded Grant
    • 3M to Sell Drug Delivery Business for $650M
    View Breaking News >
    CURRENT ISSUE

    November/December 2019

    • Adding Fabrication Capabilities: Additive Manufacturing for Production Parts
    • Delivering the Goods: The Evolving World of Combination Products
    • Anxious Undertones: The 2019 Year in Review
    • View More >
    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Deerland Obtains Certification from Australia’s Therapeutic Goods Administration
    OptiMSM Shown to Improve Hair & Nail Appearance and Condition
    DCC Acquires Contract Manufacturer Ion Laboratories
    Coatings World

    Latest Breaking News From Coatings World

    Arkema: Bostik Acquires Danish Company LIP
    Axalta Adds New Epoxy Primer to Tufcote Liquid Industrial Coatings Portfolio
    Chromaflo Technologies Promotes Sergio Duenas to Country Manager of Mexico
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FDA OKs World's First Single-Use Duodenoscope
    Dr. Stephen Hahn Confirmed as New FDA Leader
    FDA OKs First Test to Help Screen for Newborn Duchenne Muscular Dystrophy
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Sanofi Awarded $226M by US Gov't for Pandemic Influenza Preparedness
    Amgen Selects Location For R&D Facility
    Arctoris Opens Oxford R&D Facility
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Time Features 5 Best Beauty Inventions
    CES 2020 Preview - Innovation Award Honorees in Health & Wellness
    Prada & L’Oréal Sign Long-Term Licensing Deal
    Happi

    Latest Breaking News From Happi

    Cosmetic Assessments Revealed at CIR Panel
    T-Boz Launches CBD Line
    DRF and Flowerkist Develop CBD Range
    Ink World

    Latest Breaking News From Ink World

    Ripon Printers Adds Ricoh Pro C9210
    LogoJet Opens Bogota, Colombia Office
    Canon Solutions America Powers University of Notre Dame Athletics' Printing Capabilities
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    GSE products provide quality assurance for Pharmalabel
    Luminer promotes Heather Bookman to prepress manager
    Materials Exchange launches to solve excess inventory issue
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    DuPont to Acquire Osmosis Specialist
    Nice-Pak to Expand in Indiana
    Hospeco Launches Compact Fem Hy Dispenser
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    FDA OKs First Test to Help Screen for Newborn Duchenne Muscular Dystrophy
    Europe, North America Comprise More Than 80 Percent of Global Bone Marrow Transplantation Demand
    TriMed Closes Out FDA Warning Letter
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    3D Printing Materials Market to Grow at 23.9% CAGR Through 2025: GVR
    Kyocera, TactoTek Collaborate on Injection Molded Structural Electronics Solutions
    Toray Opens R&D Innovation Center for the Future

    Copyright © 2019 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.