Submissions

Submissions to an authority or notified body involves a high degree of strategic thinking.

When submitting the required documents, the health authority or notified body will send back a list of questions to be answered. Taking the utmost care to only address and answer the specific questions as well as only supplying precisely the documentation asked for is essential to make the submissions process as smooth and painless as possible.

Successfully answering questions during the submissions process takes experience and a knack for filtering out all but the most relevant and required information to be submitted. Our regulatory affairs specialists will work closely with clients to make sure that only the necessary information gets through to the authority or notified body. We will challenge our clients in a friendly and respectful way to achieve this goal.

Getting quickly through the submissions process will not only save your organization time and money, but also help get the medical device to market faster.