Are you prepared for the crucial role of Person Responsible for Regulatory Compliance (PRRC) as required under EU’s MDR (2017/745) and IVDR (2017/746)? Is your organization in compliance with Article 15? The understanding and implementation of these regulatory requirements is of paramount importance for every manufacturer of medical devices, regardless of their location globally. Key…
In today’s landscape of increasingly connected devices, the fusion of healthcare and technology offers transformative opportunities in patient care. However, this digital evolution also opens a Pandora’s box of cybersecurity vulnerabilities, particularly in medical devices. Recognising this pressing issue, the US Food and Drug Administration (FDA) recently issued new regulations aimed at mitigating these risks.…
Free Webinar: Shift Left on Security with Patient Zero 21 September 2023 via Zoom Presenters: Dan Dekel, David Capper & Joe Cooney Want to dive deep into the realm of cybersecurity? Want to turn theoretical understanding into pragmatic applications? Join us for a hands-on approach! On 21 September at 11am (NZST), we’re pleased to invite you…
Join us for an insightful workshop centered on the regulatory landscape of Software in Medical Device (SiMD) and Software as a Medical Device (SaMD) products. This event is jointly presented by Te Tītoki Mataora and HealthTech Activator, key players in the health tech industry. Details and Location The workshop is scheduled for the 3rd of…
Presented in collaboration by The Johner Institute New Zealand, Te Tītoki Mataora, and HealthTech Activator Join us for an intensive exploration of regulatory requirements for Software in Medical Device (SiMD) and Software as a Medical Device (SaMD) products. This comprehensive workshop is a collaboration between The Johner Institute New Zealand, HealthTech Activator, and Te Tītoki…
Do you need help understanding the new US Food and Drug Administration’s (FDA) legal requirements for cybersecurity in medical devices? We’ve got you covered. On August 17th at 11 a.m. (NZST), join us for a free, one-hour webinar on “FDA Cyber Security: From Guidance to Legal Requirements”. This virtual event, conducted over Zoom, is designed…