Introduction to medical device product and company development in a regulated environment

NEW DATES: Medical Devices – An Introduction to Product and Company Development in a Regulated Environment

Discover how to successfully bring a medical device to market in this comprehensive 2-day introductory course by Elevate Medtech on 20 and 28 November. Designed for those involved in product development and sales, business owners, founders, and CEOs, this course offers an in-depth overview of implementing a quality management system (QMS) and navigating regulatory requirements.…

PRRC, person responsible for regulatory compliance under EU MDR

Seminar PRRC – Person Responsible for Regulatory Compliance – Nov 23-24

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…

Medical software regulatory requirements – SaMD compliance guide

Workshop – Medical Software Regulatory Requirements (3 August 2023)

Presented in collaboration by Elevate Medtech, 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 Elevate Medtech, HealthTech Activator, and Te Tītoki Mataora. The Opportunity and Venue Scheduled…

FDA cybersecurity requirements for medical devices – free webinar registration

Free Webinar: Unpacking the FDA’s New Cyber Security Legal Requirements for Medical Devices

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…