Professional training on ISO 13485, ISO 14971 and ISO 15189 provides key knowledge and skills to those in the medical device industry in relation to quality management systems, risk management and quality for medical laboratories.

Bywater offers a comprehensive range of complementary courses around international requirements for medical devices. Face-to-face and virtual classroom ISO 13485 training courses provide an overview of ISO 13485 and how to perform internal QMS audits. Our associated medical device courses examine the requirements of the FDA’s QSR, product safety and the CE mark, as well as medical laboratory requirements, risk analysis, FMEA and usability engineering for medical devices. Our training can also assist organisations who are preparing for FDA/Notified Body audits.

Choose your Medical Devices course

ISO 13485 Internal Auditor Training Course | 2 days

This practical course is designed for those interested in auditing in relation to ISO 13485, the FDA’s Quality Systems Regulations and other related standards, in preparation for FDA/Notified Body audits.

For those with little or no prior knowledge of ISO 13485 we recommend first attending our Introduction to ISO 13485 training course (delivered the day before the Internal Auditor course). We offer a discount of £100 when booking these courses together.

Next Course: 16 - 17 July 2024 Online
Dates & Venues

Introduction to ISO 13485 for Medical Devices | 1 day

This interactive course is suitable for anyone looking for a detailed overview of ISO 13485 and how it relates to frameworks such as the Medical Device Regulations. Delegates will be introduced to a process approach to managing an organisation’s quality system.

This course is the ideal introduction for those who are planning to attend our ISO 13485 Internal Auditor training course but first need to develop their understanding of ISO 13485. We can offer a discount of £100 to those who book both courses at the same time.

Next Course: 15 July 2024 Online
Dates & Venues

Medical Device Regulation (MDR) Training Course | 1 day

This introductory course provides essential information about regulations and CE marking for the marketing of medical devices in the EU.

The course covers the key requirements for the application of the new (EU) 2017/745 regulation and explores how organisations can practically implement processes to meet its demands.

Next Course: 09 July 2024 Online
Dates & Venues

In Vitro Diagnostic Regulations (IVDR) Training Course | 1 day

This course offers an essential guide to the new EU regulations for developing, manufacturing and marketing in vitro diagnostic devices in Europe.

The practical training explains the requirements of EU 2017/746 and how to meet those demands and then support continual improvement.

Next Course: 10 July 2024 Online
Dates & Venues

ISO 14971 - Risk Analysis for Medical Devices | 1 day

This course has been designed for those who need an understanding of risk analysis with reference to the requirements of ISO 14971 and how it applies to medical devices.

The course reviews all the steps in the risk management process and how it can be used to help managers make informed decisions about taking a device to market.

Next Course: 08 August 2024 Online
Dates & Venues

Risk Analysis and FMEA for Medical Devices | 2 days

This course is suitable for those who need an understanding of risk analysis in relation to medical devices and the requirements of ISO 14971, and additionally want to learn about practical applications of methodologies.

The course examines all steps of the risk management process and explores the skills needed to apply risk analysis methodologies such as such as Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA).

Course Details

ISO 15189 Internal Auditor Training Course | 2 days

This course provides the knowledge and skills to prepare, perform and follow up an internal audit based on ISO 15189 for medical laboratories.

For those with little or no prior knowledge of ISO 15189, we recommend first attending our Introduction to ISO 15189 for Medical Laboratories training course. We offer a £100 discount when booking these courses together.

Next Course: 23 - 24 July 2024 in Central London
Dates & Venues

Introduction to ISO 15189 for Medical Laboratories | 1 day

Designed for those seeking an understanding of the quality management system requirements for medical laboratories, this course explores the specific requirements of ISO 15189.

The course is ideal as an introduction for those who wish to progress on to our ISO 15189 Internal Auditor training course. We offer a £100 discount when booking these two courses together.

Next Course: 22 July 2024 in Central London
Dates & Venues

Quality System Regulations for Medical Devices | 1 day

This course is designed for those who wish to sell medical devices in the USA and need to meet the FDA’s Quality Systems Regulations.

Delivered in-house, this practical workshop examines the demands of the QSR and product safety to enable companies to prepare for design requirements.

Course Details

BS EN 62366 Usability Engineering for Medical Devices | 1 day

This course is appropriate for those who wish to extend the scope of their current risk management activities for medical devices to ensure that the user interface is safe and effective.

Delivered in-house, this practical course provides an understanding of usability engineering and how it should be applied, by examining all steps of the usability engineering process.

Course Details