Statistical Techniques for Medical Devices and Diagnostics

Date: Jun 8 - 9, 2023.

Time: 1 PM ET to 5 PM ET

Duration: 8 hours, 4 Hrs/Day

Level: Intermediate to Advanced

Group Packages: Please contact ben@complyrules.com

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

• Why use statistics? - Regulatory Requirements and business needs
• What can I see? - Types of data and simple graphical tools
• How can I summarise?- Descriptive statistics
• Is it real? - Hypothesis testing and simple comparisons
• Why does this change? - Correlation and Regression
• How is it changing? - Time Series Analysis

DAY 02

• Day 1: look back
• What am I measuring? - Measurement System Analysis
• How do I control it? - Statistical Process Control
• What am I making? - Process Capability
• How many do I need? - Sampling
• How long will it last? - Reliability

Personalized Training: Online/Onsite

The customized training program can be done according to your time and dates, and the session will be interactive with a long Q&A session with more in-depth content purely customized for your organization. The content of the training will be modified after analyzing your data. We will arrange a call with you and the expert where you will discuss the areas where your team faces issues and the speaker will design sessions accordingly. In addition, personalized sessions give you the opportunity to discuss off-topic issues with our experts. In our customized training program, we collaborate with your team to design the agenda and the training session to ensure that your needs are taken care of. Our solutions are designed to cover your specific issues and needs. We will define a custom-made agenda after our consultation call so as to avoid any overlap or waste of time. With customized training, you'll get maximum value for your investment as the Content will be created exclusively for you and is tailored to address your organization's specific needs.

In-depth, interactive training for your organization. Sessions can be scheduled to accommodate your schedule. While we design customized training videos for each of your employees, we use advanced techniques to motivate and engage learners. We deliver effective e-learning content that is impactful and engaging. Moreover, one of our experts reviews your organization's needs and develops sessions based on this information.

Includes:

Recordings to all the participants with lifetime access, Materials, Certificates, and long Q&A sessions.