Novatek releases template for medical device product launches

Novatek Communications, provider of technical documentation and training services, has launched an Instructions for Use (IFU) template to support the product launch needs of medical device companies.

An IFU is an essential step for complying with the FDA’s Code of Federal Regulations and meeting premarket notification requirements before going to market with a new device. The IFU provides instruction from the device manufacturer to the lab technician, doctor, physician or surgeon to ensure that the professional uses the device properly and safely. Following the IFU is critical for patient safety and reliable results.

Novatek offers a do-it-yourself IFU template as well as professional editing and writing service options. This simple, flexible solution is ideal for start-ups and companies with limited budgets.

“The IFU template is designed to help start-up medical device companies, operating on shoestring budgets, meet regulatory compliance,” said Novatek president Amy Castronova. “If we can help these two-to-six person companies get their product to market with the limited funds they have, the sooner they’ll generate revenue and become sustainable.”

Once start-up companies are cash flow positive, Novatek provides a team of professional writers and instructional designers to quickly turn around customised user, service and sales documentation and training. By utilising communication professionals, the medical device inventors and engineers are better equipped to handle the new influx of customer calls. The customer experience is intentionally designed for retention.