Quality Training

Masterclass in Software as a Medical Device (SaMD)

Objectives

Join Connected Health Skillnet on Friday, 30 June at 11:00 for a 50-minute Masterclass in Software as A Medical Device (SaMD).

Medical Device Software and understanding of SaMD and Software in a Medical Device (SiMD) is challenging health tech organisations globally. It is compounded by a shortage of skills and knowledge of the nuanced and evolving regulatory requirements governing the space.

We will be joined by Niamh Lynch and Meddev Solutions who will present a high-level overview of the requirements of IEC 62304 and the importance for medical device manufacturers to help you better understand and navigate this space.

Agenda

11:00 – Welcome – Jennifer McCormack, Connected Health Skillnet

11:05 – Overview of SaMD requirements - Niamh Lynch for Meddev Solutions

• Overview of MDR 2017/745 / IVDR 2017/746 Software Requirements
• Defining the different types of software (Software as a Medical Device (SaMD); Software In a Medical Device (SiMD) – Embedded/Firmware or software as an accessory to a medical device; Non-medical software including Wellness apps, Health Services, etc.)
• Software Device Classifications and guidance from IMDRF
• Overview of IEC 62304 Software Development Life Cycle
• Summary of IEC 82304-1 Health Software
• Whether ISO 81001-1:2021 Health Software and Health IT Systems and IEC 81001-5-1 impacts you and what are the plans for harmonisation?
• Recent FDA software guidance published, e.g., Software Functions, June 2023
• Cybersecurity and vulnerability maintenance
• Understanding the importance of integration with the product realization process under ISO 13485 and Design Control 21 CFR Part 820 & QMSR

11:35 – Q&A

11: 50 – Webinar close - Katie Cooney, Meddev Solutions


This live webinar offers a flavour of the areas that will be covered in Meddev Solutions in-depth 4-day SaMD training course starting 10 July 2023, which is grant funded for industry by Connected Health Skillnet.

About the speaker

Niamh Lynch, Director of Regulatory Affairs & Quality and SaMD trainer for Meddev Solutions.

Niamh brings 30-years’ global quality and regulatory experience and knowledge spanning Software Engineering, Database Technologies and Artificial Intelligence. Her extensive career spans both the medtech and pharma sectors in Ireland, the UK and Switzerland, and includes medical device, pharmaceutical, combination products and active devices including in vitro diagnostic systems/software products with responsibility for automated software systems under GAMP4 and GAMP5.

Niamh became a leading risk and software trainer as a lead technical CE mark reviewer for NASI specialising in MDR, Risk Management, Software and New Technologies, including active devices under IEC 60601 and IEC 62304. She supported the 1^st generation guidance for SaMD developed by the MDGC New Technology Group set up by the EU Commission for identification of software requirements related to healthcare applications and new emerging technologies (AI). Niamh is a certified Lead QMS Auditor with regulatory submissions in US, EU/UK, CA and Japan including MDSAP Certification. She holds a BSc (Hons) cognitive Science (Artificial Intelligence) and Masters in Software Engineering and Database Technologies, MScSED.

Niamh is currently the Director of Regulatory Affairs and Quality for active medical device with embedded software and software accessory/component application.


For further details contact jennifer.mccormack@ibec.ie or olena.nazarenko@ibec.ie

Upcoming dates:

No training dates available at the moment.