HMC experts will work with your team on a global scale to fast-track the commercialization of IVDs products. With our in-depth knowledge of current requirements, you will understand precisely the complex legal challenges that IVDs manufacturers sometimes face. However, our goal is not for you to purely understand the IVDs, but to make your growth strategy easier and more efficient .
Whether you're supporting IVDs regulatory reviews and submissions, developing IVDR-compliant technical files, designing and managing clinical trials, or building an ISO 13485-compliant quality system: 2016 and 21 CFR part 820… we both help you.
We need whatever needs you may require, and we guarantee high quality and cost-effective results for you.