Learn about the new subclass for Class I reusable devices under MDR and the necessary steps to ensure compliance.
Validation is an obstacle to implementing technology. A streamlined approach is necessary.
The agency has issued its list of the most common inspectional observations for FY 2017.
Using advanced technology still requires validation.
An important yet often mysterious part of validation.
How to prepare for a successful transition.
The agency calls out specific devices that should include human factors data in premarket submissions, along with recommendations for combination products.
If you’re using software in the product development process, it better be validated.
Prior to design verification of packaged products, consider the following process-related elements.
Even what may appear as simple design changes need to be reviewed for the need to repeat design validation.