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

Medical Device Innovators:  Get Used to Being Uncomfortable

The latest MEDTECH 2018 conference, New York's largest gathering of bioscience and medical technology leaders, brought together experts in regulatory and policy, innovation and technology, and startup/business acceleration. This year’s event, “Building ...
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Reduce Compliance-Related Stress with Effective Project Management Techniques

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.
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FAQs:  How and Why to Budget for Medical Device Product Documentation

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 ...
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Writing for Your Audience: 6 Steps for Creating Technical Documentation That Gets Used

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 ...
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Outdated Medical Device Documentation Becomes User-Friendly

User manuals can be a make-or-break point of customer loyalty for manufacturers. The more user-friendly the product documentation is, the more likely the product will be successful. Technical documentation is especially important in the medical device ...
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 EU MDR