Articles by Mark Durivage

  1. FDA Proposes Safer Technologies Program For Medical Devices 10/2/2019

    This article examines the CDRH draft guidance Safer Technologies Program for Medical Devices (STeP) and what it means for medtech manufacturers.

  2. What Happens To ISO 13485 When Annex L Is Adopted? 9/16/2019

    Although the structure of ISO 13485 will expand from the current eight main clauses to ten, most of the QMS requirements should essentially remain the same.

  3. MDSAP's Effect On The Internal Audit Process 7/5/2018

    The Medical Device Single Audit Program (MDSAP) is recognized by officially approved Auditing Organizations (ISO Registrars) to conduct a single regulatory audit, of a medical device manufacturer, that satisfies relevant requirements of the regulatory authorities participating in the program.

  4. How To Establish Sample Sizes For Process Validation Using Statistical Tolerance Intervals 10/27/2016

    This article demonstrates how to use statistical tolerance limits, which use the confidence level (how sure we are) and reliability value (population value) to determine appropriate statistically valid sample sizes for process validation.