X-Plain Technical Writing

X-Plain's Sevices

X-Plain's services overview

Medical and Regulatory Writing

The FDA and CE certification process for medical devices involves the production of a large amount of complex and time-consuming documentation. Our regulatory writing team, led by Dr. Charles Hurwitz , can supply you with all the necessary documents for a 510k application and technical files for CE approval. In addition, we can also produce clinical trial documents (Helsinki) — including clinical protocol and informed consent.