Novatek Communications Launches IFU Template For Medical Device Manufacturers

Thursday, April 20, 2017

Source: BioSpace

Rochester, N.Y. (April 18, 2017) – Novatek Communications, Inc., a trusted 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, 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 startups and companies with limited budgets.

“The IFU template is designed to help startup medical device companies, operating on shoestring budgets, meet regulatory compliance,” said Novatek President Amy Castronova. “If we can help these 2-6 person companies get their product to market with the limited funds they have, the sooner they’ll generate revenue and become sustainable.”

Once startup companies are cash flow positive, Novatek provides a team of professional writers and instructional designers to quickly turn around customized user, service and sales documentation and training. By utilizing 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.

Novatek has 28 years of experience writing IFUs for medical device manufacturers and documentation for other industry verticals. To learn more about Novatek’s services, visit

About Novatek Communications, Inc.

Since 1989, Novatek Communications ( has helped companies in regulated and deadline-driven environments launch new products and capture key processes. Novatek provides technical writing and training services to medical device companies and other manufacturers launching new products, creating a QMS, or facing regulatory and compliance challenges. Novatek’s custom documentation and training materials result in Active Knowledge—knowledge that improves usability and customer satisfaction without complexity and confusion.


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