CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.
Moving too quickly in the product development process can lead to mistakes.
No longer just “the big company advantage,” Arlen Ward discusses how CM&S is an accepted and viable device industry path to market for large and small medical device makers alike.
To make the most accurate strips possible, it is important to be aware of issues that can arise during a test strip’s lifecycle.
The center will start phasing in efficiencies on March 18.
Risk Management is the single most important topic impacting the medical device industry today.
Standards are never sufficient to identify all the risk and handle all the risks. Why? Because there are a lot of stakeholders, and by the time the standard is announced, it’s already outdated. That’s why risk management is the glue between standards, and it is critical to ensure that risk management is an ongoing and continuous process, explains Peter Havel, Senior Vice President and Global Head of Medical & Health Services, at TÜV SÜD.
It’s not just about architecture; what are the critical systems engineering roles and responsibilities?