FDA Warning Letter Recap, November 2021: 3 Device Makers Cited After On-Site Inspections
Invacare, Smiths Medical and CellEra were cited for quality systems and Medical Device Reporting violations in the only device-related warning letters released by the agency last month.
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On this week’s podcast: From Hawaii to Missouri to Florida, the medtech industry and third-party servicers are duking it out in state legislatures over who has the right to repair and service medical devices.
Manufacturers keen on fostering a culture of quality throughout their organizations should first make sure they have a robust quality strategy in place. Here, BD’s VP of quality management & supplier quality answers a handful of questions on the topic.
The goal of the guidance is to make the Case for Quality Voluntary Improvement Program, or CfQ VIP, “more official” at the US FDA, an agency official says. CfQ VIP aims to elevate product, manufacturing and process quality at medical device firms.