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Commercial Operations

Home » Topics » Medical Devices » Commercial Operations
  • January 31, 2023

    ‘Maturity’ of Quality Culture can be Measured Through Many Channels

    Becoming — and remaining — in compliance with FDA regulations is often a result of creating and maintaining a quality culture, but measuring the maturity of that culture takes more than just looking at metrics, according to several experts in a recent FDAnews webinar.

  • January 30, 2023

    Omnipod Customers’ PHI Potentially Leaked

    Insulet announced that it has emailed 29,000 Omnipod insulin pump customers to advise them that some of their personal health information (PHI) — but not financial, social security number, email or password — was inadvertently shared with Insulet’s website performance and marketing partners.

  • January 13, 2023

    Notable Acquisitions in 2022 As Top Companies Expand Their Portfolios

    Interventional devices for heart rhythm disorders and neurovascular care, device software and assays featured among the top buyout announcements of medical device companies in 2022 — led by the Johnson & Johnson (J&J) $16.6 billion Abiomed purchase.

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  • January 3, 2023

    SeaStar and Nuwellis Ink Licensing Deal for Acute Kidney Injury Device

  • December 29, 2022

    Olympus to Acquire AI Endoscopy Developer Odin Vision

  • December 19, 2022

    Pfizer and Anumana Ink Multi-Year AI Electrocardiogram Algorithm Deal

  • December 7, 2022

    Teva Sued for Allegedly Blocking Generic EpiPen and Narcolepsy Drug

  • November 29, 2022

    Large-Scale Trial Shows Lunit Breast Cancer AI More Accurate than Radiologist Reviews

  • November 22, 2022

    HeartVista Teams With Siemens Healthineers for Cardiac MRI Exams

  • November 21, 2022

    HeartVista, Siemens Healthineers Partner to Simplify Cardiac MRI Exams

  • November 16, 2022

    Lantheus to Pay POINT Biopharma $260M for Two Late-Stage Cancer Treatments

  • November 15, 2022

    FDA Hands UFP Technologies a Form 483 for Cleanroom Controls, Other Lapses

  • November 14, 2022

    WCG Imaging Among 2022 Top 10 Device Testing Companies

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Products

  • Kara stockett quinn 500aqua

    The Inextricable Link Between Data Integrity and Quality Culture – Webinar Recording/Transcript

    $287.00
  • Schniepp steven seyed michael matthew green

    Manufacturing Quality: Using Audit Observations to Predict Problems – Webinar Recording/Transcript

    $387.00
  • Shelly garg 500aqua

    FDA Pathways to Bring your Medical Device to Market: What Regulatory Professionals Need to Know – Webinar Recording/Transcript

    $287.00
  • Dennett kouri and faviola michelot 500blue

    Building a World-Class Regulatory Intelligence and Support System – Webinar Recording/Transcript

    $287.00
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Events

  • 01Feb

    The Future of QMS: Will the Recent Announcement and Delays Have a Global Impact?

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

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