Risk Management


  • Software & Quality
    Managing Deviations and Adequately Recording Failures

    Managing Deviations and Adequately Recording Failures

    According to the ECA Academy, managing deviations and Corrective and Preventive Actions (CAPAs) are still the focus of inspectorates. The summaries of their observations show deficiencies relating to quality systems are by far the most frequently obs…
    Emily Ysaguirre, Content Marketing Writer, EtQ 11.21.17

  • Software & Quality
    Three Places for Risk Management in Life Science Organizations

    Three Places for Risk Management in Life Science Organizations

    By now, the concept of risk probably isn’t a brand new one—it has entered into many regulations, standards, and best practices. Risk-based thinking has become a cornerstone in many industries, especially those as critical as the life scie…
    Alexa Sussman, Content Marketing Writer, EtQ 03.22.17

  • Supply Chain
    Implementing Risk Strategies for the Supply Chain

    Implementing Risk Strategies for the Supply Chain

    Risk remains a major theme as approaches to quality management develop. As more companies adopt quality management as a priority, risk plays a bigger role in organizations across all  industries. Risk management is a major factor in quality and…
    Alexa Sussman, Content Marketing Writer, EtQ 11.22.16

  • An Overview of the Tools Available to Identify and Mitigate Risk

    An Overview of the Tools Available to Identify and Mitigate Risk

    Risk is crafty—it can take on the shape of many different forms, sizes and types, but if you look closely enough at your company’s data it is possible to take control. Data is constant, it never stops flowing and it can be overwhelming…
    Emily Ysaguirre, VERSE Solutions 05.23.16

  • How to Bulletproof Your Firm from Expensive Employment Liability Risks

    A grandmotherly figure with white hair peers benignly over her reading glasses in a magazine ad. The caption: “Her smile seemed to light up the office.” The ad’s small print reveals that “granny” cost her employer $425,0…
    Kevin M. Quinley, Quinley Risk Associates LLC 08.05.15

  • When National Basketball Association player LeBron James announced his decision to return to his nat

    When National Basketball Association player LeBron James announced his decision to return to his native Ohio and play for the Cleveland Cavaliers once again, the sports world went crazy. LeBron felt after his tenure with the Miami Heat that he had un…
    08.04.14

  • Can “Apology Programs” Work for Medical Device Product Liability Claims?

    Bedside manners may be hard to define, but some studies have shown that doctors who have them face fewer lawsuits. When things go wrong and adverse patient outcomes unfold, the right words can make the difference between a salvaged relationship and a…
    09.11.12

  • Seven Traits that Will Sink Your Risk Management Program

    During a recent webinar on managing corporate crises, a consultant identified seven behaviors that spell trouble regarding crisis management. In a different context, we can adapt these headings and apply them to the realm of product liability for…
    09.06.11

  • Five Medical Device Risk Management Myths … And How to Avoid Them

    Elvis lives. The moon landing was staged in a Hollywood studio. Brett Favre is too old to play pro football. Legions of believers tenaciously have held these views, which have proven to be akin to urban myths. Before we snicker at those harboring…
    02.01.11

  • Can You Avoid Avoidance … as a Risk Management Tool?

    Avoidance is something that we all likely are guilty of when it comes to taking on unpleasant tasks, roles or responsibilities. Sometimes, however, avoidance can be a good thing for medical device firms. In the quest to manage product liability ri…
    11.11.10

  • Four Risks to Expect When Facing a Product Liability Claim

    Risky Business: Four Risks to Expect When Facing a Product Liability Claim Kevin M. Quinley Product liability litigation can be disorienting for medical device professionals. In fact, device executives ensnared in the product liability proc…
    07.28.10

  • Investigating Adverse Medical Device Events: A Three-Step Approach

    Before “CSI Miami” and “Law & Order” there was “Dragnet.” In that iconic police drama, one of the program’s protagonists, Sgt. Joe Friday, became synonymous with the line, “Just the facts, ma&rsq…
    05.19.10

  • Regulatory Concerns Grow Over Outsourcing

    Regulatory Concerns Grow Over Outsourcing Marc Miller Step back with me for a moment…to 2007. The Dow Jones Industrial Average was happily climbing from 12,000 to 14,000, Bear Stearns and Lehman Br…
    08.10.09

  • Post-Riegel: Device safety and risk management

    All the same risk management strategies that made sense pre-Riegel still make sense. For life science firms engaged in medical product outsourcing though, supply chain management becomes even more vital. Those firms outsourcing manufacturing of co…
    03.13.09

  • Medical device case: Federal versus state power.

    Sports coaches often say offense wins games but defense wins championships. Medical device firms play offense by launching new products, innovating and feeding their research and development pipelines. They play defense by shielding themselves fro…
    02.04.09