Guest Columns

  1. 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.

  2. People: The Most Persistent Risk To Data Integrity

    Regardless of the maturity of an organization’s data integrity practices, the people component remains the greatest risk. The important thing for individual contributors, operational managers, and executive leaders to remember is that data integrity evolves.

  3. 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.

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

    When faced with scenarios that demand SOP remediation (outsourcing, mergers, acquisition), a common instinct is to do whatever possible to salvage the work that’s been done, believing this is the most efficient approach. However, 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.

  5. 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.

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

    In the interest of saving time and getting projects underway as quickly as possible, teams often rely on ad hoc resource allocation and a naively hopeful attitude about who is qualified and capable of bringing the plan to life.

  7. China’s Medtech Goals

    This article presents challenges facing the Chinese medtech space and details how the country’s government currently manages these issues, as well as how it plans to do so going forward.

  8. FDA Updates Several 510(k) Guidance Documents

    The FDA recently issued four final guidance documents governing 510(k) regulatory submissions, covering the Special, Abbreviated and Traditional 510(k) pathways, as well as the Refuse to Accept Policy for 510(k)s.

  9. Intro To Prefilled Syringe Selection: Staked-In Needles

    This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes. Part 2 examines the various aspects of prefilled syringes with staked-in needles and their impacts. 

  10. Applying Lean Thinking To Support Processes in MedTech, Biotech Organizations

    This article answers the question, “how can lean thinking be applied to areas like QARs, QC tests, and document control procedures to remove waste while still adhering to regulations?”