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Regulations and QMS for Software as a Medical Device online tutorial | HealthTech Activator

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Event description

The next online HealthTech Activator interactive tutorial, Regulations and Quality Management Systems (QMS) for Software as a Medical Device, focuses on the implications of regulations and standards for healthtech companies developing software for use in a medical context. 

This interactive tutorial will cover:

  • Introduction, definitions and software intended use
  • Market-dependent regulatory strategy and how it affects the development process
  • QMS required, scope, certification and when to start 
  • Development methods and what it means for the development process and the timeframe

The interactive tutorial is presented by Annett Arndt of the Johner Institute, and is ideal for businesses starting new healthtech software development projects, as well as for companies offering services such as development or testing to healthtech companies. 

It is also relevant for those that would like to know more about current regulatory and QMS requirements for healthtech software development.

Event details:

  • 9:00am-10:15am, Tuesday 29 March 2022, online via Zoom
  • The interactive tutorial will close with a 15-20 min Q&A session
  • The interactive tutorial will be recorded, but the recording will not include the Q&A
  • All who attend the interactive tutorial  will also receive a copy of the slides
  • Cost: $23 + booking fee per person. The $1.64 booking fee will be donated to the Educational Equity for Māori and Pasifika Learners

Register no later than Monday 28 March 2022.

About the presenter: 

Annett Arndt

Anne started her career as a software developer over 20 years ago, eventually working as a consultant on software projects in the food industry. On leaving the field of software development Anne changed to quality and process management, and for the last 10 years has worked successfully on the approval of medical products in Europe.

Anne joined the Johner Institute four years ago and since then has successfully supported customers in the approval of medical devices with a focus on software as a medical device. Subsequently, Anne moved from Europe to New Zealand and together with a European manufacturer, she took advantage of the 12-hour time difference and worked with a team 24 hours a day to launch a Covid tracking app onto the market after two months of successful cooperation.

In 2021, Anne was appointed as Director of Johner Institute New Zealand, and now supports clients in New Zealand and Australia in preparing their products for global approval. Anne’s focus remains on active medical devices including software. Her passion for regulatory compliance drives her to also support suppliers to medical device manufacturers, for example helping software developers and testers to understand the development of products following a regulatory framework.

Contact the HealthTech Activator (HTA) team for more information, or explore the HTA website here

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