The international standards ISO 13485, ISO 14971 and ISO 15189 are designed to support customers within the Medical Device Industry in relation to quality management systems, risk management and quality for medical laboratories.

Bywater’s in person and online ISO 13485 training courses provide an overview ISO 13485 and how to perform Internal QMS Audits. Our associated Medical Device courses examine the requirements of the QSR, product safety and the CE mark, medical laboratory requirements, Risk Analysis, FMEA and Usability Engineering for medical devices. Courses can also assist organisations who are preparing for FDA/Notified Body audits.

Interactive ISO 13485 training courses and associated Medical Devices events take place online in our Virtual Classroom, plus at UK venues including Coventry, Leeds, West Yorkshire and London throughout the year.  All delegates will be provided with training materials and a certificate upon completion.

To view all course dates please select the relevant Dates & Venues button from the ISO 13485 Course Listing.

All of our Medical Devices ISO 13485, ISO 14971 and ISO 15189 training courses can take place on a dedicated basis at a venue of your choice or online. Dedicated training is often more cost effective and convenient for organisations with several employees requiring training. Please select the following link to request a quote.

We can provide additional support to those wishing to achieve or maintain ISO 13485, ISO 14971 or ISO 15189 certification in the way of Management Systems Consultancy Services.  Please follow the link to view our ISO 13485 Consultancy Services.

Medical Devices Course Listing

  • ISO 13485 Internal Auditor Training Course | 2 days

    • Designed for those seeking to gain effective auditing techniques and increase their understanding of audit principles in relation to ISO 13485, the FDA's QSR and other related standards, in order to prepare for FDA/Notified Body audits
    • Provides the latest information on FDA Quality Systems Regulations (QSR) and product safety (CE Marking & UKCA marking) requirements, providing delegates with practical auditing techniques to conduct effective audits against the requirements of ISO 13485 and QSR
    Next Course: 07 - 08 December 2021 in Coventry
  • Introduction to ISO 13485 for Medical Devices | 1 day

    • Designed for those seeking a detailed overview of the Standard and the process approach to managing a company's quality system, its control and effectiveness
    • Provides a basic knowledge of the background, structure and requirements of the Medical Device Directive and CE marking and how the Standard relates to those requirements
    Next Course: 06 December 2021 in Coventry
  • ISO 14971 - Risk Analysis for Medical Devices | 1 day

    • Designed for those needing to develop their understanding of the application of the risk management process in the standard ISO 14971 to medical devices
    • Provides a review of all steps in the risk management process and how it can be used to provide management with information to decide whether to bring a device to market
    Next Course: 22 February 2022 Online
  • Risk Analysis and FMEA for Medical Devices | 2 days

    • Designed for those needing to develop their understanding of the application of the risk management process in the standard ISO 14971 to medical devices and practical application of methodologies to their devices
    • Provides understanding of risk analysis and how it applies to medical devices; develops the skills necessary to apply risk analysis methodologies, such as FMEA, to medical devices.
    Next Course: 22 - 23 February 2022 Online
  • ISO 15189 Internal Auditor Training Course | 2 days

    • Provides the knowledge and skills to prepare, perform and follow-up an internal audit based on ISO 15189 for Medical Laboratories
    • Develop continuous improvement that provides on-going future benefits to the organisation
    • Verify the effectiveness of corrective action
    Next Course: 17 - 18 November 2021 Online
  • Introduction to ISO 15189 for Medical Laboratories | 1 day

    • Designed for those seeking an understanding of the quality system requirements applicable to medical laboratories
    • Highlights the specific requirements of ISO 15189 over and above those of ISO/IEC 17025 and CPA requirements, focusing on the quality and competence requirements applicable to medical laboratories.
    Next Course: 16 November 2021 Online
  • Quality System Regulations for Medical Devices | 1 day

    • Designed for those needing to understand the FDA Quality Systems Regulations (QSR) in order to sell their medical devices in the USA and meet these regulations
    • Provides the latest information on QSR and product safety requirements in the USA and compares the requirements of QSR with MDD/IVDD, prepares companies for the design requirement, and provides the methods for successful implementation of the regulations
  • BS EN 62366 Usability Engineering for Medical Devices | 1 day

    • Designed for those seeking to extend the scope of their current risk management activities for medical devices to ensure the user interface is safe and effective
    • Provides an understanding of usability engineering and how to apply the usability engineering methodology in BS EN 62366 to medical devices
    • Learn to prepare the documents for the key stages of the usability engineering process
  • Understanding the European Directive 93/42/EEC concerning Medical Devices | 1 day

    • Designed for those need to understand the European Directive 93/42/EEC which provides the 'rules of the game' in manufacturing CE marked medical devices
    • Provides a detailed overview of the Directive; Regulatory Bodies and their roles are defined in the Directive, together with classification criteria and the routes to the EC Declaration of Conformity and the use of the CE mark

Other Subject Areas

ISO 17025 Training Courses

ISO 17025 Training Courses

Gain an awareness and understanding of how to plan and conduct internal and external audits of laboratories within the scope of ISO/IEC 17025.
ISO 9001 Training Courses

ISO 9001 Training Courses

Improve consistency and increase customer satisfaction with our ISO 9001 Quality Management Systems (QMS) training courses.
Root Cause Analysis Training Courses

Root Cause Analysis Training Courses

Identify the root causes of problems, prevent recurrence and improve customer satisfaction with our Root Cause Analysis training courses, for all industry sectors.