Guest Columns

  1. Analyzing The changes To Risk Management Standard ISO 14971:2019

    The third edition of ISO 14971 and its updated companion report are set for release this month. ISO 14971:2019 will provide clearer guidance and greater detail in the application of risk management concepts while aligning with essential safety and performance principles.

  2. The IMDRF Cybersecurity Guidance: A Comprehensive Analysis

    Principles and Practices for Medical Device Cybersecurity clarifies cybersecurity expectations for medtechs selling to a global market and is likely to serve as a blueprint for most regions’ local regulations, including the next round of FDA guidance documents.

  3. What Does IMDRF’s New Cybersecurity Guidance Mean For You?

    Principles and Practices for Medical Device Cybersecurity is intended to help facilitate international regulatory convergence on medical device cybersecurity by explaining fundamental concepts, best practices, and recommendations for all stakeholders.

  4. Documentation Priority For Early Stage Medtechs — Part 1: User Specification

    This article lays out considerations and a process for developing user specifications when developing a new medical device. It is the first in a series that examines – and prioritizes -- necessary documentation when creating early an proof-of-concept prototype.

  5. What Is the Current State Of BREXIT, And What Happens Next?

    The United Kingdom’s plan to leave the European Union, with PM Boris Johnson still at the helm, now hinges on the results of an early election taking place Dec. 12, 2019, and refinement a transition period effective through Dec. 31, 2020. Zaid Al-Nassir's breakdown for medtech leaders has been updated to include events taking place through Nov. 8, 2019.

  6. People: The Most Persistent Risk To Data Integrity

    HR changes continually impact overall data integrity—from a single new hire to a corporate-level change with a merger or acquisition. It's a commonly overlooked weak link in the data integrity chain.

  7. FDA's Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program Explained

    The ASCA Pilot is intended to provide increased confidence in testing results from ASCA-accredited testing laboratories, as well as decrease the burden of individual premarket submissions when manufacturers rely on testing completed by ASCA-accredited testing laboratories.

  8. SOP Remediation: When Reinventing The Wheel Is The Best Approach

    When faced with scenarios that demand SOP remediation (outsourcing, mergers, acquisition), repurposing processes, written content, templates, etc., can be the worst possible and most expensive approach when you factor in time, human resources, and long-term outcomes.

  9. The European MDR: Impetus, Impacts, And Current Status

    This article explains the MDD’s shortcomings, details the MDR’s history, highlights expected transition timelines, describes the most significant changes, and discusses the anticipated impact on medical device markets.

  10. Closing Quality Gaps: 7 Steps To Properly Resource A Remediation Project

    Teams often rely on ad hoc resource allocation and a naively hopeful attitude about the qualifications and capabilities of project team members. These tips can help you avoid such mistakes and improve the chances of your project's success.