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QT Activity: Qualtech's Year-end Updates 2023 – January/February 2024

QT Activity: Qualtech's Year-end Updates 2023 – January/February 2024

  • 2024-01-26 07:26:23

Reflecting on 2023, Qualtech experienced a dynamic and transformative year marked by regulatory webinars and the establishment of a new office in Korea. Amid challenges and celebrations, we fortified our commitment to excellence, setting the stage for continued growth and even greater achievements in the future. Join us in revisiting the highlights that shaped our journey.

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QT ACTIVITY: QUALTECH DRIVES GROWTH IN THE ASEAN REGION THROUGH TRANSFORMATIVE BUSINESS DEVELOPMENT MEETING  - DECEMBER/JANUARY 2024

QT ACTIVITY: QUALTECH DRIVES GROWTH IN THE ASEAN REGION THROUGH TRANSFORMATIVE BUSINESS DEVELOPMENT MEETING - DECEMBER/JANUARY 2024

  • 2023-12-26 05:15:49

Qualtech's regional meeting united leaders from across ASEAN to collaborate, share knowledge, and shape the future of Qualtech in the region. The event focused on fostering unity, unwavering commitment to quality with ISO 13485 standards, and strategic planning for each country's unique needs. A cultural immersion tour of Chulalongkorn University provided inspiration and deeper understanding. The meeting concluded with a shared vision for the future of Qualtech in ASEAN.

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QT ACTIVITY: KOREA MARKET EXPANSION AND CHINA NMPA UPDATES WEBINAR SUMMARY - NOVEMBER/DECEMBER 2023

QT ACTIVITY: KOREA MARKET EXPANSION AND CHINA NMPA UPDATES WEBINAR SUMMARY - NOVEMBER/DECEMBER 2023

  • 2023-11-20 03:05:02

On October 20, Qualtech hosted a webinar titled "Korea Market Expansion and China NMPA Updates." With over 60 global participants, the event marked Qualtech's entry into the Korean market, sharing actionable steps for successful medical device registration. The second segment covered key changes in China's Medical Device regulations from September 2022 to August, ensuring attendees were informed about the latest regulatory developments.

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QT ACTIVITY: QT JAPAN WEBINAR SUMMARY – SEPTEMBER/OCTOBER 2023

QT ACTIVITY: QT JAPAN WEBINAR SUMMARY – SEPTEMBER/OCTOBER 2023

  • 2023-09-27 07:52:28

Qualtech's webinar on medical device registration in Japan highlighted the critical aspect of reliability inspection. Key topics covered include the registration process, PMDA's role, and the requirements of the reliability inspection. The webinar provided valuable insights into this complex process, facilitated by expert speakers from Qualtech.

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QT ACTIVITY: SUMMARY OF QUALTECH'S ACTIVITY – JULY/AUGUST 2023

QT ACTIVITY: SUMMARY OF QUALTECH'S ACTIVITY – JULY/AUGUST 2023

  • 2023-07-21 03:58:08

Qualtech hosted a talk by Dr. Huang Wen-Chien on the evolution of minimally invasive lung cancer treatment. The advancements discussed included surgical tools, non-surgical techniques, and video-assistive technology. Qualtech also offers comprehensive Clinical Evaluation Report (CER) services to assist with medical device registration, drawing upon expertise in biomedical engineering and molecular biology to deliver high-quality reports for various regions.

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QT Activity: Summary of Qualtech's Webinar on the EU MDR Updates from February 7, 2023 – February/March 2023

QT Activity: Summary of Qualtech's Webinar on the EU MDR Updates from February 7, 2023 – February/March 2023

  • 2023-02-23 02:33:41

Qualtech, in cooperation with Mr. Arkan Zwick of Austrian Manufacturer Croma-Pharma GmbH, have organized a webinar on the important updates pertaining to the EU MDR on February 7, 2023. Topics discussed include the European Commission's Proposal to extend the MDR transition period as well as the validity of MDD certifications, and our suggestions regarding the critical steps to be taken in order to smoothly obtain approval under the MDR. The content of the webinar has been briefly summarized in this article.

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QT ACTIVITY: Qualtech's Japan Webinar Provided a Detailed Overview on the Japanese Regulatory System – SEPTEMBER, 2021

QT ACTIVITY: Qualtech's Japan Webinar Provided a Detailed Overview on the Japanese Regulatory System – SEPTEMBER, 2021

  • 2021-10-04 05:18:22

On September 17th, Qualtech hosted its Webinar on the subject of Japan Medical Device Registration to an international audience of MD manufacturers. During the event, the Qualtech team thoroughly explained the Japan registration process and elaborated on aspects such as registration timelines, product classifications, and consultation sessions with PMDA.

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