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

Scheduled Training

Our interactive ISO 13485 and associated Medical Devices training courses take place in Coventry, Leeds, West Yorkshire and London throughout the year and are also available online.  All delegates will be provided with training materials and a certificate upon completion.

To view all course dates please select the Dates & Venues button next to your preferred Medical Devices training course below.

Dedicated Training

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.

Consultancy

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 find out more.

Medical Devices Course Listing

  • Introduction to ISO 13485:2016 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: 12 October 2020 Online
  • ISO 13485:2016 Internal Auditor 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) requirements, providing delegates with practical auditing techniques to conduct effective audits against the requirements of ISO 13485 and QSR
    Next Course: 13 - 14 October 2020 Online
  • 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: 12 November 2020 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: 12 - 13 November 2020 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: 17 November 2020 in Coventry
  • 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
    Next Course: 18 - 19 November 2020 in Coventry
  • 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
  • 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

Laboratories Training Courses

Laboratories 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.