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Quality

Home » Topics » Medical Devices » Quality
  • September 14, 2020

    Hazard Analysis Key in Risk Management for Combo Products

    It’s possible to learn from failures resulting in unacceptable risks for combination drug-device-biologic products what design input requirements are essential to the safe and effective operation and use of such products, Susan Neadle, head of combination products at Johnson & Johnson, said at the World Drug Safety Congress Americas.
  • September 11, 2020

    Hazard Analysis Key in Risk Management for Combo Products

    It’s possible to learn from failures resulting in unacceptable risks for combination drug-device-biologic products what design input requirements are essential to the safe and effective operation and use of such products, Susan Neadle, head of combination products at Johnson & Johnson, said at the World Drug Safety Congress Americas.
  • September 16, 2019

    Russia Implements New Quality Control Requirements

    Russia’s Ministry of Health has rolled out new requirements for internal quality control and monitoring of the safety of devices in medical facilities.
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  • May 3, 2019

    NEMA Issues New QMS Standard for Servicing Imaging Equipment

  • May 15, 2018

    FDA Releases Guidance on Quality Considerations for Inhalers

  • April 13, 2018

    NSF Names Medical Device Certification Director

  • Redwarningstamp
    February 6, 2018

    Medical Laser Manufacturer Draws Lengthy FDA Warning

  • January 19, 2018

    CDRH Seeks Participants for Manufacturing and Product Quality Pilot Program

  • January 18, 2018

    Warning Letter Roundup: FDA Warns Devicemakers in India, Lithuania, Texas

  • January 18, 2018

    CDRH Seeks Participants for Manufacturing and Product Quality Pilot Program

  • January 5, 2018

    Patient Engagement Continues to Grow, Despite Difficulties

  • December 29, 2017

    Warning Letter Roundup: Firms in India, Lithuania and Texas Draw Warnings

  • December 28, 2017

    GPC Medical Lands Warning Over Process Validation, Labeling Problems

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Products

  • Eric henry blue500

    Medical Device Cybersecurity: Understand the Latest Developments – Webinar Recording/Transcript

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  • Michael m gaba 600red

    Is Your Product a Drug or Device — and Does It Matter?: A Recent Appeals Court Decision Says It Does – Webinar Recording/Transcript

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  • James pink 600green

    EU-MDR’s Growing Pains: Are You Current with the Latest Developments? – Webinar Recording/Transcript

    $287.00
  • Richard kingston and diane mcenroe 600red

    Recall Readiness: Dust Off Your SOPs, There’s a New Guidance in Town – Webinar Recording/Transcript

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Events

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 28Jul

    EU-MDR’s Growing Pains: Are You Current with the Latest Developments?

  • 28Jul

    Is Your Product a Drug or Device — and Does It Matter?: A Recent Appeals Court Decision Says It Does

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