US FDA

We can give you professional registration service, based on Plenty of Experience of Preparation & Review of 510(k) submission.

Ex UL Asian-Pacific lead Review and ex 510k reviewer of HQ of UL are participating as our members.

We are recording highet success rate and have various clients groups which may cover various kinds of products

We are providing support for whole process, from preliminary preparation to final approval, including documentation, submission, and communication during interactive review, and also supporting clients to get proper testing reports with communication with testing laboratories

We are cooperating our whole process with our partner IRC LLC in Arizona USA. We can handle whole process by ourselves but can get support of IRC in review of documentation & related counselling. IRC is also supplying US Agent Service including Establishment Registration and Product Listing for the clients from outside of USA

We established joint-company in Korea, IRC Korea, to make our relationship more strong. Please refer to web-site of IRC (www.irc-us.com)

CE(MDR/IVDR)

More than half of our consultants are participating projects related to CE Marks. The total record of our consultants exceeds 50 products.

We can cover comprehensive range of product categories and can support intensive service through whole certification process from preliminary preparation to final approval.

In case of clients from outside Europe, we can supply Authorized Representative Service via our European partner.