This section is dedicated to open discussion, letters or comments to the editor, and straight answers to direct questions. Unabridged and to the point. Some example topics of interest that we would like to address in the future:

- Interpretations to be aware of from the FDA, registrars and notified bodies;
- How to swith your registrar or notified body;
- Down-to-earth solutions to their findings;
- Obstacles in the way of meeting international standards and regulations;
- Global harmonization: What does it really mean, and why are most of us not seeing benefits of it?
- CE marking in Europe: Is it really working? And what about the MRA?
- Japanese SHONIN: Insurmountable obstacle or just another cultural and language challenge?
- Supplier quality overseas: How to stay on top with your suppliers;
- Meshing Lean Manufacturing and Six Sigma with a regulated quality system;
- And any other topic that you would like to talk about!

So, we ask for your feedback. Send us an e-mail with your particular questions, comments or anecdotes, and we will respond to you and perhaps even put your comments onto this page. Your inputs will remain anonymous, unless you wish to be quoted!