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This article outlines the key elements of ISO 13485, explains its role in regulatory compliance, and explores how staff training and general quality awareness are essential to ensuring the system works in practice.
This article outlines the key elements of ISO 13485, explains its role in regulatory compliance, and explores how staff training and general quality awareness are essential to ensuring the system works in practice.
Introducing a new Quality Management System learning series, brought to you by the HealthTech Activator in partnership with Johner Institute New Zealand.
Introducing a new Quality Management System learning series, brought to you by the HealthTech Activator in partnership with Johner Institute New Zealand.
Insights and key takeaways from the Clinical Investigation Process for Medical Devices Workshop, held on 10–11 June 2025, facilitated by Julie Jones, CEO of BioValeo.
Insights and key takeaways from the Clinical Investigation Process for Medical Devices Workshop, held on 10–11 June 2025, facilitated by Julie Jones, CEO of BioValeo.
Insights and key takeaways from the Medical Software Regulatory Requirements Workshop on the 27 May, facilitated by Anne Arndt, Director of the Johner Institute New Zealand.
Insights and key takeaways from the Medical Software Regulatory Requirements Workshop on the 27 May, facilitated by Anne Arndt, Director of the Johner Institute New Zealand.
A Q&A with Abbas Al-Murrani offering practical guidance to help HealthTech founders understand and apply health economics.
A Q&A with Abbas Al-Murrani offering practical guidance to help HealthTech founders understand and apply health economics.
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