最新消息

Qualtech Webinar: Accelerating Innovation: Why Australia is the Ideal Partner for Your Next Clinical Trial – July 2025

Qualtech Webinar: Accelerating Innovation: Why Australia is the Ideal Partner for Your Next Clinical Trial – July 2025

  • 2025-07-07 08:26:29

Join Qualtech's upcoming webinar, "Accelerating Innovation: Why Australia is the Ideal Partner for Your Next Clinical Trial" to explore how Australia's clinical trial environment supports faster, cost-effective, and globally recognized medical device development. The session will feature insights from Mobius Medical Pty Ltd, Qualtech's CRO trusted partner in Australia, and highlight key advantages including expedited approvals, R&D tax incentives, and data acceptance by major regulators such as the U.S. FDA.

了解更多
QT ACTIVITY: NAVIGATING INDIA'S MEDICAL DEVICE REGULATORY LANDSCAPE WEBINAR RECAP - MAY/JUNE 2025

QT ACTIVITY: NAVIGATING INDIA'S MEDICAL DEVICE REGULATORY LANDSCAPE WEBINAR RECAP - MAY/JUNE 2025

  • 2025-06-03 07:01:37

On April 24, 2025, Qualtech hosted a webinar focused on navigating the regulatory landscape for medical devices in India. The session was presented by Mr. Anil Chaudhari, Founder and CEO of Operon Strategist, and Ms. Lakshmi Ranjith, Manager of Regulatory Affairs of Operon Strategist. Together, they provided a detailed overview of India's regulatory system, including the roles of CDSCO and state licensing authorities, the classification of medical devices by risk level, the registration process, and best practices for compliance. The following summary highlights the key insights and essential regulatory requirements, offering valuable guidance for medical device companies seeking to enter or expand in the India market.

了解更多
QT Activity: Medical Device Approval in Australia – What You Need to Know in 2025 Webinar Recap – April/May 2025

QT Activity: Medical Device Approval in Australia – What You Need to Know in 2025 Webinar Recap – April/May 2025

  • 2025-04-24 09:48:40

On March 26, 2025, Qualtech hosted a regulatory webinar exploring the process of medical device approval in Australia. The session covered essential topics including device classification, conformity assessment options, ARTG registration steps, sponsor and manufacturer obligations, post-market surveillance, and upcoming UDI requirements. Practical tips and FAQs helped attendees better prepare for TGA submissions and long-term compliance in the Australian market.

了解更多
QT Activity: 2025 Updates & Forecast for European Medical Device Regulations Webinar Summary Recap – February/March 2025

QT Activity: 2025 Updates & Forecast for European Medical Device Regulations Webinar Summary Recap – February/March 2025

  • 2025-02-21 05:38:28

Qualtech hosted a webinar providing key insights into the evolving European medical device regulations. The discussion covered essential updates, including the MDR transition period extension, Article 10A supply notification requirements, the gradual rollout of EUDAMED, the implications of the European AI Act, and regulatory changes in the UK and Switzerland. Attendees gained valuable guidance on compliance strategies and proactive measures to navigate these regulatory shifts.

了解更多
QT Activity: Introduction to India's Medtech Market Webinar Summary Recap – October/November 2024

QT Activity: Introduction to India's Medtech Market Webinar Summary Recap – October/November 2024

  • 2024-11-05 02:46:36

India's MedTech industry is quickly becoming a key player in global healthcare, driven by government initiatives, rising health awareness, and growing medical tourism. The India MedTech 2024 webinar, hosted by Qualtech Consulting, highlighted trends, challenges, and opportunities in the sector, featuring insights from expert Sandeep Shah. While the market, valued at $11-12 billion, still relies heavily on imports, there is a shift toward local manufacturing and innovation in digital health and AI. With growth prospects in domestic production and rural healthcare, the industry is poised to reach $50 billion by 2030.

了解更多