Educational seminars on all aspects of product development for medical devices with electronics hardware and software
All webinars include 30 to 40 mins of presentation followed by 20 to 30 minutes of questions
In this session of the NSW Active MedTech Community we collaborated with Venture Cafe Sydney to brainstorm what it would take to rapidly develop an Automatic Ventilator from scratch, in Australia. The discussion worked with real requirements for ventilators that have been published by governments at the height of the Covid-19 pandemic. A plausible design was presented and a panel of experts were invited to make comment, along with the audience.
18 Mar 2020 - Setting up your ISO 13485 quality system
Every manufacturer of active medical devices must have a quality system in place. This webinar outlines the processes and best practices in getting your system ready for audit.
The most important standard in MedTech is the ISO 13485 standard on quality management systems for medical devices. This standard sets out the requirements for regulatory purposes. The founder of Ora Innovations, Kevin Badin, will outline what companies need to do to successfully establish their quality systems for medical devices.
18 Mar 2020 - Software and electronics - overview
Software and electronics is what makes a medical device "active". This presentation breaks down the hardware development process for electronics as well as the corresponding firmware and software development process. An overview is given of the IEC 60601-1 standard for medical electrical equipment and the IEC 62304 standard for medical device software. The webinar is presented by Genesys CEO Geoff Sizer. Geoff has over thirty years of experience designing electronic devices.
19 Feb 2020 - Obtaining grants to support your MedTech journey
Grants feature strongly in the development of almost every active MedTech project. In this webinar, the full range of grants available in Australia is outlined. The webinar is delivered by the CEO of Pattens Group, Bruce Patten. His company has assisted individuals and companies apply for grants. Previously, Bruce was Group Finance Controller for bionic ear company, Cochlear Limited, which provided him with extensive experience in securing a range of government grants and the formulation of strategies to substantially assist company growth.
12 Jan 2020 - Regulatory requirements for Active Medical Devices
This 40-minute presentation explores the compliance and certification requirements for creating and marketing active medical devices. The two main regulatory regimes around the world are examined. The critical role of the technical file and how it applies to different regulatory processes is explained. The role of harmonized standards and quality systems in the regulatory compliance process is also explored. The webinar is presented by a senior consultant at Brandwood CKC, a leading regulatory consultant for medical devices.
This presentation is a high-level overview of the product development process for active medical devices. We explain how active devices are different from inert MedTech, the range of service providers needed to bring your product to life and the complex web of quality systems, regulatory processes and product certification. This webinar is aimed at people considering developing a medical device and service providers wanting to understand the big picture outside of their field.