The Rules of Acquisition
Medical Devices acquisitions are difficult and can lead to compliance issues. This article contains a list useful Rules of Acquisition a company can take to ensure the acquisition is successful.
Translating an FDA Warning Letter: What the FDA Really Means
What the FDA really means when it issues a Warning Letter to a Medical Device Manufacturer.
“Level” Up Your Design Inputs!
There are many way to write good Design Inputs, but the key is to really understand the structure of your Design Inputs to set yourself up for success.
New FDA Draft Guidance: FDA Provides 510(k) Cheat Code
FDA is providing real useful information to help design better medical devices and get them to market quicker.
Schrödinger’s User Needs
The FDA does not explicitly require User Needs, but it does expect them to be created, defined and validated.
You don’t need to do design verification testing.
Understanding how testing really fits into your entire design verification efforts.
Help! Do I need to complete design verification before starting design validation?
Auditors hate this one trick when it comes to verification and validation testing!
