Bringing an IVD to the regulated marketplace involves a number of considerations and systems. To help start the process, here are some introductory articles on the kinds of things a IVD marketer will need to know.
These articles are very general in nature and should not be taken as specific advice for a particular product. If you would like more detailed information about what your project may need to consider, please give us a call.
- Medical Device Classification »
- Intended Use Statements »
- Laboratory Developed Tests »
- Quality System Regulation »
- IVDMIA »