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  • Conducting Remote GxP Audits: Three Keys to Success

    Conducting Remote GxP Audits: Three Keys to Success

    While remote audits have always been an option, the pandemic forced quality units to take a fresh look at how to use them effectively.
    Online Exclusives Paula Pilecki, Sr. Director of Project and Audit Management, MWA Consulting Inc. 05.07.21

  • Chronic Disease | Diagnostics
    GE Healthcare Buys Zionexa, a Breast Cancer Dx Startup

    GE Healthcare Buys Zionexa, a Breast Cancer Dx Startup

    Acquired molecular imaging agent aims for more targeted metastatic breast cancer treatment.
    Sam Brusco, Associate Editor 05.06.21

  • Chronic Disease
    BD to Spin Off Diabetes Care Biz

    BD to Spin Off Diabetes Care Biz

    Transaction is expected to be completed in the first half of 2022.
    Sam Brusco, Associate Editor 05.06.21


  • R&D & Design
    Overview of the Medical Device Design History File, Technical File, and Design Dossier

    Overview of the Medical Device Design History File, Technical File, and Design Dossier

    The FDA requires manufacturers to follow design control principles to ensure that specified design requirements are met.
    Online Exclusives David Butcher, Staff Writer, MasterControl 05.06.21

  • Digital Health
    Connect America to Buy Philips

    Connect America to Buy Philips' Aging and Caregiving Biz

    Combined business will service expanded customer base of Personal Emergency Response System.
    Sam Brusco, Associate Editor 05.05.21

  • Software & IT
    Digitization Streamlined Quality and Production: A Case Study

    Digitization Streamlined Quality and Production: A Case Study

    Recognizing that managing a paper-based quality system was no longer practical, the company took steps to modernize with digital solutions.
    Online Exclusives David Butcher, Staff Writer, MasterControl 05.05.21


  • Diagnostics
    COVID Diagnostics from Beckman Coulter—A Medtech Matters Podcast

    COVID Diagnostics from Beckman Coulter—A Medtech Matters Podcast

    MPO's Sean Fenske speaks with Chris Hagen of Beckman Coulter about the company’s response to the need for COVID diagnostics and the rapid ramp-up of production.
    Sean Fenske, Editor-in-Chief 05.04.21

  • Embedding Risk-Based Thinking into Quality Efforts

    Embedding Risk-Based Thinking into Quality Efforts

    Controlling risk is an important requirement for companies developing regulated products.
    Online Exclusives David Jensen, Staff Writer, Master Control 05.04.21

  • Spectrum Plastics Group Acquires Laser Light Technologies

    Spectrum Plastics Group Acquires Laser Light Technologies

    Advances the group’s offerings as a full-service partner for medical devices, life sciences, and other applications.
    Charles Sternberg, Assistant Editor 05.03.21


  • Video & Analytics: Differentiators in a Compliance-Adherent Crowd

    Video & Analytics: Differentiators in a Compliance-Adherent Crowd

    Instead of checking the box with minimal investment in compliance, the firm that elevates its manufacturing practices beyond cGMP will gain more market share.
    Prasad Akella, Founder/CEO, Drishti 05.03.21

  • R&D & Design
    Medical Device Design for Smaller and Smarter Medtech

    Medical Device Design for Smaller and Smarter Medtech

    Developers of medtech are asked to reduce the size of devices, and fortunately, can take advantage of newer tools that better enable them to do just that.
    Mark Crawford, Contributing Writer 05.03.21

  • Respiratory Equipment

    Respiratory Equipment's Pandemic Spotlight

    Ventilator and critical component manufacturers supercharge production to meet COVID-19’s demand for respiratory aids.
    Sam Brusco, Associate Editor 05.03.21

  • Contract Manufacturing
    Medtech

    Medtech's 2021 Full Service Outsourcing Roundtable

    Outsourcing service providers share lessons learned and how they were able to tackle the COVID-19 challenges to fulfill the needs of their OEM customers.
    Sean Fenske, Editor-in-Chief 05.03.21

  • Defying the Laws of (Mask) Supply and Demand

    Defying the Laws of (Mask) Supply and Demand

    Cases of N95 respirators are piled high outside the headquarters of Prestige Ameritech.
    Michael Barbella, Managing Editor 05.03.21

  • Fertility Treatments—A Patient Self-Pay Paradise

    Fertility Treatments—A Patient Self-Pay Paradise

    According to the National Conference of State Legislatures, the average IVF cycle costs between $12,000 and $17,000 (not including medication).
    Maria Shepherd, President and Founder, Medi-Vantage 05.03.21

  • Paying it Forward: How Mentorship Pushes Us to Success

    Paying it Forward: How Mentorship Pushes Us to Success

    The right people can build us up, push us to excel, and persevere when we think we can’t go on.
    Dawn A. Lissy, Founder & President, Empirical 05.03.21

  • A Lifetime in Medtech: MassMEDIC’s Brian Johnson  Offers a Snapshot of the Industry

    A Lifetime in Medtech: MassMEDIC’s Brian Johnson Offers a Snapshot of the Industry

    Johnson shares his thoughts on a number of pandemic-related topics, from lessons learned to the need for changes in the supply chain.
    Sean Fenske, Editor-in-Chief 05.03.21

  • Surgical
    High-Quality Materials and Precision Engineering in Robotic Medical Technology

    High-Quality Materials and Precision Engineering in Robotic Medical Technology

    The XACT ACE Robotic System is designed to be able to deliver an instrument to a target within 1.7-mm average accuracy on the first insertion.
    Chen Levin, CEO, XACT Robotics 05.03.21

  • A Paradigm Shift—Third-Party Immersive Execution

    A Paradigm Shift—Third-Party Immersive Execution

    A reputable firm will provide a thorough and unbiased review of all portions of your business and supply fractional leadership where you may have gaps.
    Kevin Haines, Partner, Factor 7 Medical 05.03.21

  • Ensuring Regulatory Compliance for Medical Device Manufacturing

    Ensuring Regulatory Compliance for Medical Device Manufacturing

    EMS providers have highly experienced quality teams that intimately understand the regulatory landscape for developing safe and effective medical devices.
    Tim McGinnis, Vice President, Medical Quality and Regulatory Affairs, Sanmina 05.03.21