ISO 14155:2020 – An Update and Practical Implementation

11:05 AM - 11:55 AM

The new version of ISO was published in July 2020. It brings quite a few important highlights for medical device clinical professionals. Amongst the many changes and additional guidance, one important point that is brought forward is the absolute need to consider important input from risk management and the clinical evaluation of existing data before embarking on designing a clinical investigation. This presentation will bring an overall update on the new or reinforced requirements of ISO 14155 for clinical investigations with medical devices with a special focus on the writing of the essential documents and closing the loop between Risk Management, Clinical Evaluation and Post Market Planning and Reports.