Novatek Communications Launches IFU Template for Medical Device Manufacturers

Rochester, NY (April 19, 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. Learn more about Novatek’s services.

 Novatek President Selected as EO Global Trainer

Rochester, NY (March 17, 2016) – The Entrepreneurs' Organization has selected Amy Castronova, CEO of Novatek Communications, Inc. as a global trainer. Amy has just completed extensive certification, which will allow her to provide training for entrepreneurs joining the organization.

While EO is a voluntary organization of peer-to-peer learning, Amy will train entrepreneurs on core skills that carry over to the medical device and manufacturing companies that Novatek serves, such as:

  • Facilitating exchange of knowledge
  • Effective tactics for communication and learning
  • Structured approach and documentation for presenting ideas and challenges

Amy and the team at Novatek utilize the latest techniques and skills like these to help companies create training and documentation programs that turn knowledge into action.

Technical Writer Featured as Hot Job

Rochester, NY (March 10, 2016) – The Rochester Democrat & Chronicle's recent 'Hot Jobs' feature provided readers with a look into the career of a technical writer. As a profession that is typically viewed as a necessary evil or afterthought for many businesses, it was a pleasant change to see the true value of the position be given attention.

The article centered around Novatek technical writer Stephanie Bazinet, explaining the precise and complex nature of her work while highlighting its importance in specific industries.

At Novatek, we know the value each of our outsourced technical writers add to a project and we are excited to see their skills being highlighted.

Novatek & Launch Team Share Blog Series Highlighting Medtech Trends and Challenges

Rochester, NY (November 6, 2015) – Novatek Communications, Inc. has partnered with marketing services firm Launch Team, Inc. to create a medical device industry blog series for the second consecutive year. The series includes market insights from recent conferences as well as tips for product launch, usability, product positioning, marketing and documentation strategies. The series' blogs, video, and podcast are as follows:

  • Differentiating Through Usability
    • Read why usability in a commoditized environment, such as medical device, benefits manufacturers trying to differentiate themselves.

Check out the Novatek blog to see what other topics the series covers during November.

Novatek's medical device expertise will help you plan, develop, produce and maintain your medical device product documentation so you can focus on your top priorities.

Novatek Communications President Amy Castronova named to MedTech Board of Directors

Rochester, NY (October 26, 2015) Amy Castronova, President of Novatek Communications, Inc., a training and documentation company serving the medical device industry, was named to the MedTech Board of Directors.

The appointment was announced at the association’s annual conference this month. The conference shares industry trends and changes with its member companies. MedTech is committed to collaboration, education and advocacy among New York pharmaceutical, biotech and medical technology companies, their suppliers and service providers, and research universities, through its regular programs and events throughout the state.

Castronova joined MedTech in 2009, and has volunteered with the association ever since. “I dedicate my time because the work of the association is important to drive collaboration and innovation for member companies, including many of the medical device companies Novatek serves,” Novatek President Amy Castronova stated. “New York legislation, FDA regulation, and health care reform are creating unprecedented speed of change and pressure on medtech companies. I’m excited to be part of an active group seeking solutions.”

The Novatek blog regularly shares medtech news and key insights into the medical device market. Amy speaks and writes on ways training and documentation improve safety, compliance, patient care and results, and medical device sales.

 Panel Encourages Women in STEM

Rochester, NY (April 15, 2014) Novatek President Amy Castronova was a panelist at “The Power of Women in STEM” event April 9 at Syracuse University. The event, hosted by MedTech Association and WISE Women's Business Center, focused on encouraging females to take advantage of education and career opportunities in STEM fields, particularly in New York State.

The need for STEM education and training is apparent, as more jobs are being created in science and engineering fields. In New York State specifically, the bio/med industry is growing fast. New York’s medical technology cluster ranks 8th in the nation, and its bioscience industry is among the top 10 states in terms of size.

Along with job growth, however, high tech companies are facing a skills gap. Many employers report that they are unable to find qualified people with four-year STEM degrees as quickly as needed, which is affecting productivity and revenue. A gender gap compounds this issue, with studies showing that the number of women in STEM jobs is still considerably low, due in part to biases in the field. The panel was one step toward helping eliminate both gaps.

Other speakers included keynote presenter Nancy Rurkowski, vice president of Biologics External Manufacturing at Bristol-Myers Squibb; panelist Susan Abu-Absi, director of Manufacturing Sciences & Technology at Bristol-Myers Squibb; and panelist Kate Brodock, adjunct professor at the Newhouse School of Public Communications at Syracuse and president of the non-profit Girls in Tech.

Blog Series Highlights Medical Device Product Launch Strategies

Rochester, NY (November 7, 2014) In October, Novatek Communications partnered with marketing and IP development firm PLS Launch Solutions to create a Medical Device Product Launch Blog series. The series included medical device market insights as well as tips for product launch planning and implementation, PR, marketing and documentation strategies. Posts in the series are as follows:

Novatek Communications Introduces Process Protection to Help Manufacturers Meet Compliance Requirements

Rochester, NY (April 23, 2014) – Novatek Communications, Inc. introduced today Process Protection, a quality systems documentation service designed to help regulated companies meet compliance requirements faster.

Process Protection services include an assessment of quality system documentation or procedures currently in place, gap analysis with regulatory standards, and technical writing services to document and refine standard operating procedures and create company-specific work instructions. This service can help medical device and other industry manufacturers faced with:
• FDA consent decree or citation
• ISO certification process
• Centralization or standardization of processes

“Regulatory challenges cost the medical device industry billions every year due to lost revenue, market share, reputation and stock prices,” Novatek President Amy Castronova stated. “Novatek helps to manage the risk by ensuring that operating procedures are documented in a way that meets compliance standards, but also are used in day-to-day operations.”

The new Process Protection offering includes a jumpstart approach and leverages Novatek’s 25 years of experience in regulated environments to speed time to compliance. Learn more.

Novatek President Recognized as Small Business Person of the Year

“We believe in Doing Whatever It Takes, Delighting Our Clients, and Integrity in Everything We Do.” —Amy Castronova

Novatek’s CEO, Amy Castronova, was recognized as a 2013 Business Person of the Year by the Small Business Council of Rochester at a luncheon held yesterday at the Rochester Convention Center. The gala was attended by approximately 800 people, including a cheering section of Novatek supporters.

Each year, the Small Business Council of Rochester presents awards to community leaders who have contributed to the growth of their companies, excel at leadership, and give back to the community. Finalists are selected from small firms in two categories: firms with more than 50 employees and firms with less than 50 employees. Amy was the winner in the less than 50employees’ category; Mark Davitt, president of Continental Service Group Inc., which does business as ConServe, received the award in the more than 50 employees’ category.

New York’s Lieutenant Governor Robert Duffy, a former police chief and mayor of Rochester, was the keynote speaker.


Check out related local articles on the event:

Rochester Business Journal
Democrat & Chronicle – Newsprint
Democrat & Chronicle – Online
WHEC – Channel 10

Novatek recognized by Ortho Clinical Diagnostics for successful VITROS 5600 Integrated System Operator Online Training
Novatek was recently recognized for its work on the Ortho Clinical Diagnostics VITROS 5600 Integrated System Operator Training. A customized e-learning course was created to train customers on the operation of a new blood analyzer, in preparation for a 3-day instructor led course. This worldwide training was designed to minimize cost and save 8 hours of classroom training. Learn More

This award joins other honors our technical writing team has received recently:

  • Certified Quality Supplier at  Carestream Health for DIRECTVIEW CR product launch
  • Certified Quality Supplier for Kodak
  • 2012 MedTech award for greatest increase in service provider employment
  • Rochester Top 100 Company (2003)
  • Department of Defense Patriotic Employer


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