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.

Streamlined patient recruitment for clinical trials with Qualtech's extensive network

Patient recruitment is a major challenge for clinical trials nowadays. Qualtech has established extensive connections with hospitals and clinics, this enables multiple sites selection to expedite investigation process. Besides, our team of cooperative and experienced physicians are potential principle investigators. They are trustworthy leaders who can foresee risks and provide preventive measures during the trial, as to ensure completion within tight schedule. Thus, with the help of Qualtech advanced frontline medical network, we can achieve a productive outcome in our clinical trials.

Multi-country submission

We further offer multi-country registration solutions: ONE tailor-made and innovative clinical trial protocol suited to your priorities, and which can accelerate the obtainment of international approvals for your medical devices. Manufacturers can thereby overcome challenges not only in the clinical investigation phrase, but also in the registration approval process, which facilitates rapid access to the international markets.


2. Step out to the global markets - Our diverse regional expertise awaits you!

Qualtech executes registration worldwide. A talented and multi-disciplinary professional team provides you with solutions to the international registration requirements. So that you achieve compliance and gain access to targeted markets quickly and cost effectively.


Comprehensive clinical trial protocol design

    At Qualtech, we prioritize safety and cost effectiveness above all else. Hence, we proactively explore budgetary competitive items to demonstrate product’s functions when necessary. Also, having analyzed product’s features and performed literature reviews, we can propose extra investigation plans to expand indications of the products, so that they are accessible to a wider range of users. 


For more details, please check out the enclosed Case Study information to gain insights in Qualtech projects.


  1. 1. Proton therapy equipment

  1. 2.  Collagen

Excellent governance: From clinical investigation to registration application submission

Qualtech is committed to operational excellence, we thus deliver proactive and customized services. By our operational expertise, we are ready to tackle any arising challenge during all phrases of your device development. Besides, the regulatory affairs team at Qualtech has a vast network for acquiring global regulatory intelligence. Seamless co-operation between multi-professional experts guarantees an outstanding outcome.


Please contact your Qualtech experts now for a free consultation!