Are you developing or interested in developing Software that could be used as a medical device? Are you unsure about the regulatory requirements required to do this?

Translation Manchester and The Christabel Pankhurst Institute, Translation theme, are pleased to announce a training opportunity for researchers on the regulatory requirements, both technical and clinical, for developing Software as a Medical Device (SaMD).

This training is funded by the Wellcome Trust via the Translational Partnership Award and delivered by clinical digital consultancy firm Hardian Health. Hardian Health is the UK’s leading SaMD consultancy, with a track record of regulatory approvals in all major global jurisdictions.

The course is designed for researchers wanting to learn more about bringing their Software as Medical Device to market in a regulatory compliant way. Hardian Health will be delivering two live interactive online webinars in early 2024, designed for researchers wanting to learn more about how to commercialise their research and bring SaMDs to market in a regulatory compliant way. These sessions focus on two main aspects of regulatory compliance – technical regulatory factors and clinical evaluation.

Prior to attending the webinars, participants will be given access to pre-recorded resources in the form of bitesized videos and short exercises. These resources will provide essential background to the live sessions and will equip participants to get the most out of the interactive training.

Participants will be able to submit questions to the trainers prior to the live sessions based on what they learned from the pre-recorded resources.

Details and dates for the webinars are provided below. Further info on the trainers can be found here. To reserve a place on the course, register at this link.

Technical Regulatory webinar

23rd January 2024 10:00 – 12:00

TOPICS COVERED

• Intended use & examples of risk classification, comparing EU CE to US FDA 
• Benefit risk analysis
• Software development lifecycles
• Quality management systems
• Cybersecurity

Clinical Evaluation webinar

27th February 2024 13:00 – 15:00

TOPICS COVERED

• Clinical evaluation plans
• Literature review
• Clinical investigations
• Clinical evaluation reports
• Post market clinical follow up

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