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Qualtech Webinar: Navigating Medical Device Studies in the US - Regulatory Strategy, Study Design, and Subject Management - March 2026

Qualtech Webinar: Navigating Medical Device Studies in the US - Regulatory Strategy, Study Design, and Subject Management - March 2026

  • 2026-03-04 08:36:52

Join Qualtech's free webinar, "Medical Device Studies in the US: Regulatory Requirements, Study Design, and Best Practices in Subject Management" on March 26, 2026. This complimentary session is designed to provide clear and practical insights into US regulatory expectations, study design considerations, and effective subject management strategies.

Take advantage of this opportunity to strengthen your understanding of US medical device study requirements

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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.

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QT ANALYSIS: A Summary of the Regulatory Updates in the ASEAN Markets as Based on Qualtech's ASEAN Webinar – May/June 2023

QT ANALYSIS: A Summary of the Regulatory Updates in the ASEAN Markets as Based on Qualtech's ASEAN Webinar – May/June 2023

  • 2023-05-24 07:33:47

Qualtech's big topic article for this month's edition represents an overview of the recent and upcoming changes implemented in the ASEAN countries of Southeast Asia. We thereby cover 6 ASEAN countries and review the most critical and noteworthy changes, so that our readers remain up-to-date and can take required actions in a timeline manner.

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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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