Effective management teams should be fully engaged with their business operations.
If you’re using software in the product development process, it better be validated.
There’s no excuse. FDA really does make it easy.
Inspections are inevitable. If you receive 483s, follow these tips to quickly and adequately respond to the agency.
Failure to provide records during an inspection will undoubtedly lead to a warning letter.
You need a management representative with oversight over medical device quality.
Remember, several basic regulatory approvals are required.
Get an instant warning letter with repeat Form 483 observations.
With decreasing prices and increasing regulation, many UK medical device businesses are looking to emerging markets for growth. However, compliance issues are also problematic in those territories, according to a recent study from life science consulting firm Maetrics.
Facilitating a RI department can quickly become an expensive proposition. Adding a vision system, mechanical inspection tools, a reasonably-sized surface plate, and hiring/training competent mechanical inspectors is not cheap. However, device establishments can mitigate some of the costs by implementing some pretty basic inspection concepts.