When the New York State Department of Financial Services (DFS) mandated that financial services companies take more extensive cybersecurity measures to help safeguard their clients’ data, W.J. Cox Associates, Inc. was unsure how they’d find the time and expertise among their staff to assess their cybersecurity risk and implement a comprehensive plan that recognizes and mitigates that risk.Read More
The Novatek Blog
Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.
Workplace stress is not uncommon, especially for those who work in a heavily regulated industry, such as medical device manufacturing, where FDA compliance deadlines loom.Read More
When launching a medical device product, providing easy-to-use, accurate instructions are critical in order to operate, service, or sell the device. But developing highly professional product documentation requires a certain skill set that may extend beyond the manufacturer's internal resources.Read More
Good technical documentation doesn’t just happen. Producing professional content that's both technically accurate and user-friendly is a highly specific skill. While many companies have subject matter experts (SMEs) in-house, they may not have a professional writer on staff who can translate complicated product knowledge into content that's easily understood by the end-user.
All product managers have carefully designed plans and well thought out strategies to achieving objectives. For medical device manufacturers, technical documentation should be one of those carefully planned strategies needed to achieve product success and regulatory compliance. And a technical writing team is a key player in achieving that goal.
Documentation nightmares can be a headache for product managers, instructional designers, or project managers. In our years of experience as an outsourced technical writing company, we have heard a lot of stories about technical documentation gone wrong. We usually hear something that sounds like...
Working in one of the most regulated industries, medical device manufacturers are subject to stricter requirements and audits by the US Food and Drug Administration (FDA). Quality system implementation and management makes compliance more easily achievable for manufacturers. However, failure to implement can result in product quality and regulatory compliance issues as well as a lack of process improvements.
Because it's so important to product adoption and success, medical device training can be a big dilemma for many manufacturers. If you're looking for a solution to your training program, consider blended learning. Blended learning combines conventional instructor-led classroom learning with online and mobile learning. This mixture of learning styles provides a more flexible and comprehensive knowledge-transfer experience for participants. Freeing instruction, information, and interaction from time and place is an ideal solution for individuals with access to today’s instant technology. Plus, blended learning programs can provide organizations with cost savings.