Case-study-background

Blog

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

Who's On Your Clinical Evaluation Report Team?

As organizations grapple with the challenges of developing an EU MDR-compliant Clinical Evaluation Report (CER), the first question after “What is a CER?” is usually, “Who will write it?” Assembling the right team with the right skill set is critically ...
Read More

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 ...
Read 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 ...
Read More

6 Skills  Needed to Create Successful Technical Documentation

Like in any profession, becoming a technical writer requires a mastery of certain skill sets. The following are the top six skills a modern day technical writer needs to successfully develop technical documentation:  
Read More

Where Does Your Quality Documentation Fit in the Project Plan?

As a documentation manager, at what point in the project life cycle do to you begin developing Quality Documentation? Some managers might wait until a project is almost completed to introduce this documentation, but doing so can make tasks harder to ...
Read More
 EU MDR