Labeling Labeling includes not only the information provided on your product, but also literature that accompanies the product. Specific information needs to be included on your product or
its immediate container, and on its outer box to comply with FDA and CE requirements. Many standards also dictate the information that has to be included with a product, and where this must appear. Both
the FDA and CE countries base testing requirements to gain marketing clearance of new medical products on intended use. Thus, the labeling of a product has a great impact on the testing required to gain regulatory
approval. In addition, labeling be carefully worded to assure that your products can be used in the fashion that you intend, and are not used in other ways that are potentially dangerous to the patient.
There are serious liability issues and potential consequences associated with the words that accompany your medical products. Phil Triolo and Associates are familiar with the FDA's and EN's labeling requirements, and
has experience generating labels, instructions for use, and other literature for medical products and services. Contact us to discuss your labeling requirements.
Technical Documents Phil Triolo and Associates have generated numerous technical documents, including business plans for technical start-up companies, laboratory procedures for educational products, and Small
Business Innovative Research (SBIR) grants. Our broad technical expertise base in medical products, coupled with excellent communication skills allows us to provide concise written material to advertise your
product, educate consumers on its use, or generate a financial interest in your company. Contact Phil Triolo to discuss your specific requirements. |
