Developing and using technical documentation and standard processes is a way of life for FDA-regulated companies. The Code of Federal Regulations (Title 21, CFR Part 820) states repeatedly that the medical device manufacturers must “establish and maintain” procedures. To do so, regulated manufacturers should define, document, and implement process documentation. After implementation, it is critical to then follow up, review, and revise these technical pieces as needed.
The Novatek Blog
Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.
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.
Standard Operating Procedures (SOPs) are written instructions that a worker follows to perform a given task consistently and effectively. These documents communicate who will perform the task, what materials are necessary, where and when when the task must be performed, and how the worker will execute the task. Well-written SOPs are a cornerstone of quality system documentation, and they contribute to the scalability of a company.Read More
It's MEDTECH season again and, as we do each year, Novatek and Launch Team are taking a close look at the current trends, changes and technologies that are impacting the medical device industry. From product launches to new sales models, we're examining the 2018 outlook and sharing our insights.Read More
For companies in regulated industries, effective Standard Operating Procedures (SOPs) are important to the ability to manage quality control and process protection. Below we share best practices and tips for developing and managing an SOP process that can help companies meet the challenges that come with regulation standards.
Artificial Intelligence (AI), such as chatbots, is increasingly within reach for many businesses as customer service shifts to the web. Many companies looking to implement an element of AI in their customer service will discover that the technology only exacerbates a common problem: inconsistent and undocumented customer service policies and processes.Read More
Topics: Process documentation
Many businesses develop Standard Operating Procedures (SOPs) to ensure consistency in their processes, improve product quality, and prevent health and safety issues. An SOP is a written set of step-by-step instructions on how employees should complete a specific task or process. Its purpose is to ensure the successful outcome of the activity each time it is completed. For example, medical device manufacturers establish SOPs to make sure that employees comply with FDA regulations and follow quality management best practices.
Maintaining consistency in business process is essential to successful operations in any organization. For many manufacturers, the development and implementation of Standard Operating Procedures (SOPs) is one way to ensure quality and reduce risks.Read More
It is no surprise that many companies these days are trying to do more with less. In fact, the majority of the medical device companies that contact Novatek state that the reason for outsourcing is they don’t have expert resources of their own. While Novatek’s purpose is to make end users’ lives easier through documentation and training that improves usability and operational efficiency, this becomes even more critical when the end user is an employee in your company. As companies become leaner, accurate process documentation becomes critical to support cross-functional operations.Read More
For manufacturers in regulated industries, inconsistencies among product documentation or training materials can leave users confused and conflicted, not knowing which information is correct. On the contrary, alignment between documentation and training can positively impact process efficiency and user experiences, contributing to a successful product launch.Read More