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Medical Device Trials

This one-day course is ideal to provide evidence of regulatory inspectors that sponsor, CRO and investigator site personnel have been appropriately trained in the ISO 14155 requirements for conduting clinical investigations of medical devices. This course will introduce, explain and discuss fundamental concepts and current issues relating to compliance, human subject protection, research development and clinical investigation in the current regulatory environment for medical device clinical trials. Knowledge of ISO 14155 is essential to everyone working on medical device clinical trials and for those who work with clinical trial professionals. Regulatory inspectors now look for evidence that professionals working on clinical trials have received regular training in ISO 14155 and also understand how to company with ISO 14155 requirements. By The End Of This Course, You Will Be: - familiar with the most important areas of ISO 14155 - understand the most important principles of ISO 14155 - ensure that informed consent procedures are properly implemented for device trials - understand the requirements for Ethics Committees and Institutional Review Boards and how to obtain approvals - understand the responsibilities of the Sponsor and Investigators - able to ensure successful preparation for ISO 14155 inspection and audit

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About Us

Since 1987, we have been delivering quality training to the pharmaceutical, healthcare, CRO and related industries. As well as delivering technical courses supporting clinical research functions, we also offer a wide range of personal development courses to ensure that skills learnt can be applied in the workplace.

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Rostrum Training Solutions Ltd

24 Lansdowne Road
RG30 4QU

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