Designed for researchers wanting to learn more about bring their Software as Medical Device to market in a regulatory compliant way

Translation Manchester and The Christabel Pankhurst Institute, Translation theme, are pleased to announce a training opportunity for researchers interested in 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.

We ask that delegates please login on Zoom 10 minutes before the start of the session.

The zoom link for both events is https://zoom.us/j/91895586614

About the course:

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. 

This registration page is for both webinars, you do not need to register twice. Once registered, please place a hold in your calendar for both webinars as follow:

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

Pre work Material

We have produced some pre-recorded resources in the form of bite sized videos and short exercises. These resources will provide essential background to the live sessions and will equip you to get the most out of the interactive training.

Session 1
We suggest allocating 1 hour 40 minutes for the completion of the pre-work exercises for session 1 (23^rd January) which can be accessed by clicking the link below.
Session 1 -Technical Regulatory Workshop Pre-work
Password: Translation2024


Session 2
You can also find the pre-work resources for our second webinar (27^th February) via the link below. For this, we suggest allocating 1 hour 10 minutes in order to complete the exercises, prior to the session.
Session 2 - Clinical Evaluation Workshop Pre-work
Password: Translation2024

If you wish to submit any questions to the trainers prior to the live sessions based on what you learned from the pre-recorded resources, please forward them to translation@manchester.ac.uk in advance of the sessions.