Medical Devices / ISO 13485, ISO 14971, ISO 15189 Training Courses

Bywater delivers a variety of courses to support our customers within the Medical Device Industry.  The programme of training courses ranges from assisting organisations in the preparation for FDA/Notified Body audits; providing a detailed overview of the quality standard for the medical device industry; examining the requirements of the QSR, product safety and the CE Mark; the specific requirements relating to medical laboratories; Risk Analysis, FMEA and Usability Engineering for medical devices.

For more information relating to course content and to request a proposal for an in-house course, please select from the course links below.

ISO 13485:2016 Internal Auditor Course

Duration: 2 Days
Available in-house only

  • 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

Introduction to ISO 13485:2016 for Medical Devices

Duration: 1 Day
Available in-house only

  • 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

Quality System Regulations for Medical Devices

Duration: 1 Day
Available in-house only

  • 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

ISO 14971 - Risk Analysis for Medical Devices

Duration: 1 Day
Available in-house only

  • 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

Risk Analysis and FMEA for Medical Devices

Duration: 2 Days
Available in-house only

  • 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.

Understanding the European Directive 93/42/EEC concerning Medical Devices

Duration: 1 Day
Available in-house only

  • 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

Introduction to ISO 15189 for Medical Laboratories

Duration: 1 Day
Public Course Locations: Manchester; Reading, Berkshire; Greenwich, London

  • 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: 24 July 2017 in Manchester

BS EN 62366 Usability Engineering for Medical Devices

Duration: 1 Day
Available in-house only

  • 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

ISO 15189 Internal Auditor Training Course

Duration: 2 Days
Public Course Locations: Manchester; Reading, Berkshire; Greenwich, London

  • 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: 25 - 26 July 2017 in Manchester