The Novatek Blog

Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.

5 Best Practices for Technical Documentation & Standard Processes  Management

Posted by Amy Castronova on Thu, Jul 19, 2018

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.

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Topics: technical writing services, Business productivity, Process documentation

Documentation of Quality System Processes: Speeding FDA Audits in Medical Device Manufacturing

Posted by Amy Castronova on Wed, May 30, 2018

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.

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Topics: outsourcing, controlling cost, Process documentation

10 Basic Technical Writing Practices for Subject Matter Experts

Posted by Amy Castronova on Fri, Dec 08, 2017

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. 

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Topics: technical writing, Quality System documentation, Process documentation

How to Make Your Medical Device Startup Look Less Like a Startup

Posted by Amy Castronova on Tue, Nov 21, 2017

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.

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Topics: Process documentation, medical device launch, cyber security

Improving Quality Control & Process Protection: Developing an Effective SOP Process

Posted by Amy Castronova on Fri, Sep 08, 2017

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.

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Topics: Quality System documentation, Business productivity, Process documentation, SOPs

Technical Documentation Required for Chatbots: Customer Service Procedures You Need In Place

Posted by Amy Castronova on Fri, Jul 28, 2017

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.

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Topics: Process documentation

Developing Effective Standard Operating Procedures

Posted by Amy Castronova on Fri, Jun 30, 2017

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.

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Topics: technical writing services, Business productivity, Process documentation

Ensuring Your Standard Operating Procedures are Effective & Usable

Posted by Amy Castronova on Fri, Mar 10, 2017

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.

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Topics: Process documentation, SOPs

Process Documentation Strategy: Reducing Quality Risk in a Lean Company

Posted by Amy Castronova on Fri, Oct 14, 2016

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.

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Topics: Process documentation, usability

Technical Documentation and Training Alignment: Ensuring Consistency in Materials

Posted by Aimee Schenck on Fri, Jul 29, 2016

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.

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Topics: training solutions, Process documentation, documentation