• 2024-12-16 10:35:14

Qualtech simplifies medical device registration and post-market compliance in China by addressing NMPA requirements with personalized guidance and localized expertise. From ensuring submission-ready dossiers to managing regulatory feedback and proactive surveillance, their support streamlines compliance, safeguards product reliability, and enhances market success.

• 2024-10-10 10:03:44

The ASEAN region is rapidly emerging as a vital player in the global healthcare industry, offering immense opportunities for growth and expansion. For medical device companies looking to enter this dynamic market, partnering with Qualtech Consulting Corporation provides the expertise, support, and local knowledge necessary to navigate the complexities of regulatory approval and achieve success. Don't miss the chance to expand your business in one of the world's most exciting healthcare markets—let Qualtech guide you every step of the way.

• 2022-07-26 10:49:59

As part of the partnership between Qualtech and Australia-based Baron Rubber, we would like to provide our clients and readers with contract manufacturing services for all types of medical silicone, plastic, and rubber components. Therefore, Baron’s expertise and service scope has been summarized in the following article.

• 2022-07-26 10:43:03

Given the international trend of more and more authorities requiring the implementation of Unique Device Identification, such as by US FDA, via the new European MDR, as well as by Taiwan FDA, Qualtech would like to share with our readers a useful tool to help you establish your UDI management system. That is, via the UDI Generator and Label Management System called "UDiBar" by WhaleTeq.