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QT service highlight: Clinical Trial Service and Case Study

QT service highlight: Clinical Trial Service and Case Study

  • 2023-05-30 02:10:17

1. Qualtech is Part of Your Team

Given the constantly changing medical device regulatory environment, Qualtech is ready to be an essential part of your RA team. That is, we provide you with one-stop services to navigate you through the different global markets and to expedite your regulatory approvals in your target countries.

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AUSTRALIA: EU MDR Transition Web Publication Services – May/June 2023

AUSTRALIA: EU MDR Transition Web Publication Services – May/June 2023

  • 2023-05-24 07:26:30

TGA offers an online publication service to provide market notifications to healthcare providers and/or end users as a result of the EU MDR Transition.

If ALL 6 of the eligibility criteria for streamlined market notifications are met, then the Online Notification Form is to be submitted.
For changes that do not meet ALL six criteria, the new recall notification(s) under TGA compliance will need to be followed.

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QT Activity: CLINICAL EVALUATION REPORT (CER) SERVICES

QT Activity: CLINICAL EVALUATION REPORT (CER) SERVICES

  • 2021-06-24 02:55:03

We are happy to announce that Qualtech offers extensive services for Clinical Evaluation Report (CER) writing! Shall a CER be of interest for your business, please refer to the information within. Feel free to contact us for a first consulting session on this matter!

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Post-market surveillance Services

Post-market surveillance Services

  • 2020-11-09 10:51:43

Post-market surveillance has become an inexorable trend around the globe.
Therefore, proactively collect and track the following information of your products is essential and crucial.
-Relative post-market incidents reported (e.g. alerts, AEs, recalls)
-Relevant clinical literatures

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