Safe and Effective Instructions for Use The intent of most device instructions is to provide necessary and useful information in a form that can be easily read and understood. Medical device instructions are intended to provide adequate directions for use such that the device can be used safely and effectively. The responsibility for assessment of […]
Read MoreTag Archives: Healthcare technology
The Service Manual Problem
New Standard for Access to Medical Equipment Service Manuals: My latest blog on the long-running battle over adequate access to service manuals for purchasers of medical devices. Comments on TJC announcement of new elements of performance regarding manuals, procedures, technical bulletins, and other information requirements.
Read More