Orthopedic Insights


  • Quality, Recalls & Risk
    A Risk-Based Approach to QMS: ISO 13485:2016 Requirements

    A Risk-Based Approach to QMS: ISO 13485:2016 Requirements

    Among numerous major changes contained within the revised ISO 13485:2016 standard, a risk-based approach is perhaps the most notable alteration affecting all areas of the quality system. The 2003 version of the standard addressed risk management in r…
    Bryan Brosseau, RAC, Vice President, Quality and Regulatory Affairs, Secure BioMed Evaluations 11.21.17

  • Incorporating Payer Requirements into the Development Process

    Incorporating Payer Requirements into the Development Process

    With the current U.S. healthcare payer system, planning for payment during the development process is critical. Early assessment of payer requirements is key to selling a device after U.S. Food and Drug Administration (FDA) clearance. (Note, this col…
    Bryan Brosseau, RAC, Vice President, Quality and Regulatory Affairs, Secure BioMed Evaluations 08.15.17

  • Regulatory & Legal
    Enhanced CE Mark Requirements for Clinical Evaluation Reports

    Enhanced CE Mark Requirements for Clinical Evaluation Reports

    The European Union’s requirements for CE marking significantly changed with last summer’s fourth official revision of MEDDEV 2.7/1. From the standpoint of those who ensure a project’s documents are compliant and properly submitted f…
    Linda Braddon, Ph.D., President and CEO, Secure BioMed Evaluations 05.19.17

  • Testing: How to Approach Change in Orthopedic Device Manufacturing

    Change is inevitable, and the orthopedic device industry is no exception. Manufacturers of orthopedic devices may experience change related to the device materials, and/or the process involved in the manufacture of the device. With either type of cha…
    Alexa Tatarian and Thor Rollins, Nelson Laboratories Inc. 04.01.15

  • A New Sales Model for a Changing Orthopedic Market

    It’s no surprise that the market for orthopedic products is robust and rapidly expanding given the dynamics of an aging population and an insatiable demand for medical technology. Aging Baby Boomers want to live longer, more active lives and of…
    Martin Gold, Technology Access Partners 09.19.07