Handled by us worldwide – Approvals and Registrations of Medical Products
As a leader in Minimally Invasive Medicine, we are familiar with the high safety demands that are placed on products worldwide. This is especially true with approvals and registrations by national authorities. As part of our services, we support you with our experience and expertise across borders.
CE, FDA, CFDA – all of the important Seals of Approval
We take care of all important approval processes on your behalf. This applies to registrations in Europe as well as in North America and Asia. In addition to the certification of the European CE marking, we also handle communication with the U.S. FDA (Food and Drug Administration). To date, 40 FDA approvals have confirmed our successful work. We also know the processes that are important for Chinese CFDA and Japanese PMDA approvals. You can rely on WOM.
We speak many Languages
Our products are marketed around the globe in over 30 countries. Product manuals in the respective local language are part of our services. Manuals for our products have been published in 28 languages, including Chinese, Korean, and Arabic.
Do you have questions about a pending approval or registration? We will gladly help you. You can reach us by e-mail at info.berlin@wom.group. We will get back to you ASAP.