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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

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

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 ...
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10 Basic Technical Writing Practices for Subject Matter Experts

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

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

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 ...
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