Search Results for 'incorporate'

Search For:
Refine by Dates:
From: To:
Refine By Content:

  • Software & Quality
    Medical Device Quality: Why Software Is More Challenging Than Hardware

    Medical Device Quality: Why Software Is More Challenging Than Hardware

    The U.S. Food and Drug Administration’s (FDA) Quality System Regulation 21 CFR Part 820.30(g) states, “Design validation shall include software validation and risk analysis, where appropriate.” The words, “where appropriate,&r…
    Dan Goldstein, Manager, Quality Assurance, Musculoskeletal Clinical Regulatory Advisors 03.21.18

  • 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

  • Spine/Neurology

    Amendia Launches New Corpectomy Device

    Available for thoracic and lumbar indications, the inCORPorate is designed to replace a diseased vertebral body.
    Amendia Inc. 03.17.16