This expertly designed Medical Devices online course provides a comprehensive overview of the current regulatory landscape, incorporating the EU Medical Device Regulation (MDR) – fully applicable since 2021 – along with ISO 14155:2020 and relevant guidance from global regulatory bodies including the FDA and MHRA. The MDR replaces the previous Medical Devices Directive (MDD) and introduces more rigorous requirements for safety, performance, and clinical evaluation.
Through a highly interactive and engaging format, this course equips learners with the knowledge and practical understanding of the medical device development lifecycle, with a strong emphasis on regulatory compliance. Participants will gain insights into how to navigate complex requirements to achieve and maintain marketing authorisation.
This training is ideal for professionals currently involved in medical device clinical investigations or those seeking to enhance their expertise in the regulatory, ethical, and operational standards that govern medical device development.
The Faculty of Pharmaceutical Medicine has approved this medical device training course for CPD points.
CPD Points Available: 6
Download Course Summary Leaflet
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