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.
As medical device complexity grows, the product development process often needs to improve in order to maintain device quality and safety, foster innovation, and reduce costs. Yet teams looking to make improvements often encounter resistance from management. This Ask the Expert focuses on how you can overcome barriers to improving the medical device development process.
Despite a clear need to get better development lifecycle management solutions in place, companies are restricted by tight budgets, validation overhead, and bureaucracy. In this Q&A, Matt Harp and Angie Pepiot at Seapine Software share their insights.