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Elevate MedTech
Elevate MedTechElevate MedTech
  • Services
    • Medical Device Regulatory Consulting
    • Technical Documentation for Medical Devices
    • SaMD Compliance & Software Documentation
    • External PRRC & QMR Services
    • In-Country Representation for Medical Devices & SaMD
    • Micro Consulting for MedTech & SaMD Compliance
  • Training
    • Workshops & Inhouse Training
    • Regulatory Accelerator Programs
    • Startup Office Hours
    • Our Courses
  • About us
  • Resources
  • Contact us
  • FAQs
  • Services
    • Medical Device Regulatory Consulting
    • Technical Documentation for Medical Devices
    • SaMD Compliance & Software Documentation
    • External PRRC & QMR Services
    • In-Country Representation for Medical Devices & SaMD
    • Micro Consulting for MedTech & SaMD Compliance
  • Training
    • Workshops & Inhouse Training
    • Regulatory Accelerator Programs
    • Startup Office Hours
    • Our Courses
  • About us
  • Resources
  • Contact us
  • FAQs

Monthly Archives: March 2025

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

Courses, Seminars, WorkshopsBy Anja SegschneiderMarch 20, 2025Leave a comment

Dates: 23 July & 29 July 2025 | 17 Sept & 25 September 2025

qmsr

Top-Up Training: 21 CFR Part 820 – Preparing for QMSR

Courses, SeminarsBy adminMarch 17, 2025Leave a comment

Date: 4 & & 10 & 16 December 2025 | Time: 3 PM – 5 PM NZT | Price: NZD 800 | Place: Online via Zoom Prepare for the transition to the new Quality Management System Regulation (QMSR) with this focused six-hour training over three days. The US FDA’s adoption of ISO 13485:2016 brings key changes…

Medical Software Regulatory Requirements

CoursesBy Anja SegschneiderMarch 6, 2025Leave a comment

May 27, 9 AM – 3 PM NZST | Location: Callaghan Innovation, Auckland | Cost: $50 Johner Institute New Zealand, in collaboration with HealthTech Activator, is hosting an interactive workshop on the regulatory requirements for medical software, including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). This workshop is designed…

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