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Implementing ISO 13485:2016 and MDSAP

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This course is currently not scheduled however it can be delivered for your team. To register your interest, complete the form below

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

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.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

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.

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

Dates TBC

1 Week Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Free Online Module

 

  • Module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
  • To register for module 1, please submit your details in the form located in the agenda.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.

 

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered either online or in a classroom. Please check which course format you have booked.
  • For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

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

 

 

Richard Young has over 20 years’ experience in the medical device and IVD industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.

 

Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.

 

Richard has delivered both online and classroom training courses on ISO 13485 for both devices and IVDs. He can provide multiple examples and case studies during training, drawing on his extensive industry experience. This helps you understand quality management concepts.

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

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