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.
To view all course dates please select the Dates & Venues button next to your preferred Medical Devices training course below.
Medical Devices Course Listing
- 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
- 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
- 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
- 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.
- 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.
- 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
- 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
- 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
- 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
Premier Partnership|22nd Feb, 2021
Thames Water Utilities Ltd|12th Feb, 2021
Impedans Ltd|11th Feb, 2021
Human Fertilisation And Embryology Authority|5th Feb, 2021
Mars Nederland|3rd Feb, 2021
Science and Advice For Scottish Agriculture (SASA)|2nd Feb, 2021