17 - 20 February, 2020 | Mercure Hotel MOA Berlin, Berlin, Germany
Diarmuid Cahalane, Co-Founder and Director of Regulatory Affairs at Metabolomic Diagnostics
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Diarmuid Cahalane


Co-Founder and Director of Regulatory Affairs
Metabolomic Diagnostics

Check out the incredible speaker line-up to see who will be joining Diarmuid.

Download The Latest Agenda

Pre-Conference Workshop Day

Sunday, May 2nd, 2021


9:30 AM RISK MANAGEMENT WORKSHOP: Incorporating Recognised Standards for Risk Assessment into Software Design for Software as a Medical Device

In a rapidly evolving medical environment it is very important to establish the nature of the software that is being developed: is it a medical device, and if so what level of risk could it pose to patients? With the ongoing developments in Medical Device Data Systems, and also the forthcoming FDA regulation on Clinical Decision Support Software, it is imperative that the most appropriate regulatory strategy is followed when developing software as a medical device.
 
The proliferation of “big data” type systems as a result of the enormous cost reduction in sequencing costs has led to huge opportunities for machine learning type systems, but also created the potential for enormous risk. This workshop will help to explain how rapid developments in big data analytics and machine learning can be harnessed for the benefit of patients with as little risk to patient safety as possible.
 
Session Objectives:
 
·         Identifying an unmet medical need for a proposed device
·         Determining the classification of a device based on a risk based approach to patient safety
·         Identifying the nature of the software application: customisable, configurable, bespoke
·         Applying recognised standards (IEC: 62304) to software development
·         Relating ISO:14971,and ISO:13485 to software design as a medical device
·         Understanding the difference between Information Systems Infrastructure Qualification (ISIQ) and Software Validation well as how this is particularly relevant to cloud based systems
·         Analysing recognised industry guidelines such as Good Automated Manufacturing Practice (GAMP)
·         Identifying the nature of your software application: is it a medical device, or a medical device data system (MDSS) and the different regulatory approaches
·         Covering an introduction to the US Food And Drug Administration, (FDA) and the European Commission’s approaches to regulation of software as a medical device
·         Exploring the Software Development Lifecycle (SDLC) Approach To Software As A medical Device development 

Main Conference Day Two

Friday, July 2nd, 2021


9:55 AM Regulatory Pathways for Software Design as a Medical Device (SAMD)

        Discuss the variances in global regulatory requirements (USA/EU) and use recognised standards to demonstrate compliance with regulatory directives in the USA and Europe
        Establish the three criteria that every medical device needs for success
        Analyse the difference between Medical Device Data Systems (MDSS) and SAMD