FDA Human Factors Engineering and Usability Guidelines
The FDA describes its requirements for human factors engineering i...
Technical Documentation Best Practices for EU MDR
Manufacturers shall ensure the conformity of medical devices being...
High Level Approach for PMCF Activities
The Medical Devices field is a constantly moving area. Several dev...
Literature Search: A Medical Writer perspective
A thorough and organized search of the previously published data i...
General Safety and Performance Requirements (GSPR)
What is GSPR?        The GSPR is known as General Safety and Perf...
PMS Proactive & Reactive Data Sources for Devices
PMS processes are generating data, either continually or intermitt...
