Hardware Podcasts

Packaging Validation Best Practices

Global Medical Device Podcast · 7 Sept 2022 · 37m · Episode 279

What this episode covers

Jeff Barrett, CEO of J-Pac Medical, explains the complexities of ISO 11607 packaging validation for sterilized medical devices, emphasizing that over a third of validations fail transit testing due to a lack of understanding regarding shipping modes. He details how companies can avoid costly 510(k) delays by conducting feasibility testing, using worst-case scenarios for sterilization, and managing labeling risks, which account for 40% of FDA recalls. Barrett highlights that sterilization validations can cost $40,000-$80,000 and take 16-20 weeks, urging engineers to integrate packaging design early in the process to prevent revalidation issues as companies scale.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
J-Pac Medical, Green Light Guru
Also
ISO 11607, FDA, 510(k), ASTM

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