2-Day Virtual Seminar

Statistical Techniques for Medical Devices and Diagnostics

BY: Ian Abrahams, Director, Skylark Risk and Validation Consulting Ltd.

Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

Coming soon.. Please contact customer care for new schedule
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The appropriate use of statistical techniques is a key part of implementing, maintaining, and improving the quality management system. In the FDA Quality System Regulations (QSR) manufacturers are expected to “establish, control, and verify the acceptability of process capability and product characteristics." using statistical techniques. Additionally, sampling plans are to be “based on a valid statistical rationale”. ISO 13485 brings similar expectations.

Design, CAPA activities and Servicing are other areas in the Quality System where regulatory authorities requires the application of statistical methodology.

Whilst the regulatory authorities don’t tell us which techniques to use, the ISO Technical Report ISO/TR 10017 (2021) “Guidance on statistical techniques for ISO 9001:2015” provides a solid list of statistical methods and their potential uses within a Quality System.

In this 2 day course we will look at the range of graphical and statistical methods identified in the ISO Technical Report, and see how they align with the requirements of the FDA QSR and ISO 13485:2016.

Areas covered will include Design Controls, Production and Process Control, Acceptance Activities, CAPA and Servicing. There will be strong emphasis on selecting sample sizes for diferent situations.

For each method the principles, strengths and limitations will be examined through case studies relating to Medical Devices and Diagnostics along with suitable graphical and software tools.

Learning Objectives:
  • To appreciate the role of statistics in the development, manufacturing, control and supply of Medical Devices and Diagnostics
  • To set these in the context of customer, business and regulatory requirements (ISO, IVDR/MDR, FDA QSR)
  • To introduce a range of statistical tools useful in this field as presented in ISO 10017.
  • To illustrate the applications of the tools using generally available software
  • To provide relevant examples and exercises
  • To enable course participants to start to, or enhance their use of these tools.
Who will Benefit:
  • Quality Managers
  • Quality Engineers
  • Product Design and Development
  • Operations Managers
  • Production Managers and supervisors
  • Complaints system Managers and team
  • CAPA Managers and team
  • R&D Managers and Specialists
  • Quality Assurance and Quality Control
  • Risk Managers
Day 01(10:00 AM - 4:00 PM EDT)
  • 10:00 AM - 10:15 AM - Introduction, Meet & Greet
  • 10:15 AM - 10:45 AM - Why use statistics? - Regulatory Requirements and business needs – ISO 10017
  • 10:45 AM - 11:30 AM - What can I see? - Types of data and simple graphical tools; software selection.
  • 11:30 AM - 11:45 AM - Break
  • 11:45 AM - 12:15 PM - How can I summarise? - Descriptive statistics
  • 12:15 PM - 1:00 PM - Is it real? - Hypothesis testing and simple comparisons
  • 1:00 PM - 1:30 PM - Lunch
  • 1:30 PM - 2:00 PM - How is it changing? - Time Series Analysis
  • 2:00 PM - 2:30 PM - Why does this change? - Correlation and Regression
  • 2:30 PM - 2:45 PM - Break
  • 2:45 PM - 3:30 PM - What if I change everything? - Design of Experiments - multifactorial
  • 3:30 PM - 4:00 PM - Summary; Q&A session
Day 02(10:00 AM - 4:00 PM EDT)
  • 10:00 AM - 10:15 AM - Day 1 : look back
  • 10:15 AM - 11:00 AM - What am I measuring? - Measurement System Analysis
  • 11:00 AM - 11:45 AM - How do I control it? - Statistical Process Control
  • 11:45 AM - 12:00 PM - Break
  • 12:00 PM - 12:30 PM - What am I making? - Process Capability
  • 12:30 PM - 1:00 PM - How many do I need? - Sampling
  • 1:00 PM - 1:30 PM - Lunch
  • 1:30 PM - 2:00 PM - What if? - Simulation
  • 2:00 PM - 2:30 PM - What if I add it all up? - Statistical tolerancing
  • 2:30 PM - 2:45 PM - Break
  • 2:45 PM - 3:30 PM - How long will it last? - Reliability
  • 3:30 PM - 4:00 PM - Review of Course; Q&A session
Ian Abrahams
Ian Abrahams Director, Skylark Risk and Validation Consulting Ltd.

Ian Abrahams, BSc, PhD is an experienced professional in the Medical Diagnostics industry. He has a background in R&D, product and process development and Quality. At Orthoclinical Diagnostics, Abbott Diagnostics and most recently DiaSorin he has supported the introduction of new processes, test methods and products into new and existing facilities and followed these through to regulatory submission (FDA PMA, EU IVDD/IVDR), audit and inspection, product launch, on-market support and process improvement. He has a detailed knowledge of the FDA Quality System Regulations, ISO13485 and ISO 14971 standards and their application to Medical Devices and Diagnostics. The effective use of statistical tools, and the relationship between Validation and Risk Management are particular interests. Dr Abrahams is the Owner and Director of Skylark Risk and Validation Consulting Limited, based in the UK.

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