Implementing ISO 13485:2016 and MDSAP

Course Overview

ISO 13485 quality management systems for medical devices and IVDs provide the framework to consistently produce safe and effective medical devices. The latest version has additions such as regulatory harmonisation and a greater emphasis on risk management. In addition, many countries have committed to harmonising their quality regulations under the Medical Device Single Audit Programme (MDSAP).

This training course will provide you with the processes to ensure you implement and comply with ISO 13485. Applicable for both device and diagnostic professionals, you will learn the concepts needed to understand, develop and implement a quality management system (QMS). You will also gain an overview of the MDSAP and how to prepare your quality system for MDSAP compliance.

Key Learning Objectives

• Interpret the requirements of ISO 13485 for both devices and diagnostics as it relates to quality management systems (QMS)

• Examine the responsibilities of management under ISO 13485 to create a companywide quality culture

• Identify the steps for defining, organising and scheduling necessary quality activities.

• Examine validation throughout the manufacturing process to ensure compliance with ISO 13485

• Learn how to continually analyse, monitor and improve processes to maintain a quality management system

• Gain an in-depth review of the Medical Device Single Audit Programme (MDSAP) and explore country specific differences.

• Learn how to prepare your ISO 13485 system for the MDSAP

What is Included in a Live Online Course?

• Direct access to an expert trainer.

• Interactive and engaging sessions with exercises and discussions.

• Bitesize learning.

• Access to the Educo Life Sciences Training Portal.

• Unlimited access to the recordings for 4 to 5 weeks after the last session.

• A reinforcement session delivered 4 to 5 weeks after the course (online) providing you with extra time with the trainer.

• A validated certificate of attendance is available for you to download.

Agenda

Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal

• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training

• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges

Module 1 & 2

Structure and documentation of a Quality Management System (QMS)

• What is required by ISO 13485:2016

• Formal systems: Best Practice for document control and record keeping

The responsibilities of management under ISO 13485:2016

• How to implement responsibility within the working environment using infrastructure and what is expected

• Implementing an internal communication process and how to document this

• Management review

• Look at links between resource elements such as training and QMS document control processes.

Module 3

Product development and QMS: Resources and infrastructure

• Human resources and infrastructure

• Working environments

• Having established a basis for the QMS, explore how to bring the product through the design process to manufacturing with the supporting services…

• Medical Device file content

Module 4

Product development and QMS: Validation

• Analyse validation through the manufacturing processes:

  • Customer related processes

  • Design and development

  • Purchasing and procurement controls

  • Manufacturing

  • Servicing and Installation, Customer Property

  • Process Validation

  • Sterilisation and sterile barrier systems

• Understand the role of traceability systems, bar coding and installation/servicing:

  • Identification and traceability

  • Preservation of product

Module 5

Measurement analysis, monitoring and improvement

• Best practices for monitoring the business and it’s processes.

• Examine methods to gather data for analysis

• Understand basic statistical analysis tools

• Analyse links between these processes and the routine operation of the system and system control

Module 6

Preparation of ISO 13485 system for MDSAP compliance

• Review the Medical Device Single Audit Programme (MDSAP) program

• Detailed review of the MDSAP system and how to best prepare for it

• Examining the country specific aspects of the application of MDSAP

Module 7

Expectation of a MDSAP assessment

• Review audit guidance for these assessments

• Provide case study examples of typical inspections and routes of enquiry

Who Should Attend?

This course is suitable for professionals who are involved in the quality management system of their device or diagnostic (IVD) product. These include: Quality | Regulatory Affairs | Design & Development | Engineers | Management | Device Manufacturers | Device Distributors