A guide to the steps companies can take to evaluate their device developer’s HFE process.
If an activity is not documented, it did not happen.
The Inspiris Resilia valve is intended for aortic valve replacement.
When responding to a 483 observation, clarity is a must: Both in communication and documentation.
An electrical test failure code could cause the device to fail to initiate therapy.
Reusable devices have become more difficult to clean, disinfect and sterilize. FDA is now requiring clear instructions for effective reprocessing.
The device should be carefully matched to end users, rather than be an afterthought.
How much do you know about this standard? Review the results.
Part II of the ISO 13485 IQ test digs a little bit deeper into the standard.
The demands of a connected device means product designers should change their approach to software development.