FDA feels so strongly about the importance and composition of the DHR, that the Quality System Regulation (21 CFR, Part 820) contains a section dedicated to this.
Notified bodies are not created equal nor are their auditors; and also, do not be afraid to push back.
Unfortunately, Mr. Murphy is alive and well in the medical device industry, and it is inevitable that device manufacturers will have to handle non-conforming product.
Creating a simple-to-use product is vital to creating a great user experience in any industry, but in the medical industry, simplification can, quite simply, save lives.
Medical device manufacturers should have a tool for communicating supplier issues back to their suppliers; and it’s always better to have documentation.
If you have not registered with FDA as an establishment and your organization meets the requirements delineated within Part 807, then what is stopping you?
Not all auditing firms or auditors are created equal; in fact, there is “The Good, The Bad, and The Ugly” when it comes to auditors.
Why audit suppliers? We explain why some audits are necessary while most are not.
It’s okay to disagree with a Form 483 observation; however, it is up to the offending organization to draft a salient response that delineates the points of disagreement.
Why should we go back to using water as a solvent? Water-based chemistry has simple operations, high synthetic efficiency, safety benefits, low-cost reactions, and a high potential to generate new synthetic methodologies that can that can be patented to protect your product.