Facility Falsified Sterilization Data
Medtech Matters
English - July 27, 2021 13:00 - 39 minutes - 27.3 MB - ★★★★★ - 5 ratingsHealth & Fitness Technology medtech medical device oem contract manufacturing Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we dig into a story about an Italian firm that reportedly falsified information related to sterilization certificates going back as far as 2016. On June 2, 2021, the FDA published a letter to industry regarding the firm Steril Milano. In the letter, the agency stated it was working with a number of manufacturers and other partners to determine the scope of medical devices affected and contact any potentially impacted firms. Specifically, the following questions are addressed:
Listen to this episode and see what you think of this sterilization situation. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.
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