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Understanding the Roles of Dye-Leak and Bubble-Leak Testing in SBS Validation

Ensuring the integrity of the sterile barrier is paramount when validating medical device packaging. ASTM F2096 (Bubble Leak Testing) and […]

April 2, 2024

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Navigating the De Novo Process versus a 510(k) Submission

In the ever-evolving landscape of medical technology, innovators are constantly pushing boundaries to bring novel solutions to the market. One […]

March 21, 2024

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Should I Combine Shelf-Life Testing with Performance Testing?

We are often asked about our recommendations for conducting performance testing (distribution testing) and stability testing (aging testing). The question […]

February 29, 2024

• Blog

ASTM D4169 – 2023 Revision is Here!

ASTM D4169 is a consensus standard practice that provides a basis for simulating, in a laboratory, the ability of medical […]

February 21, 2024

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Understanding Endotoxin Testing in the Medical Device Industry

Endotoxin testing, also known as Bacterial Endotoxin Testing (BET), plays a crucial role in ensuring the safety of medical devices. […]

January 16, 2024

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Navigating Packaging Performance Testing: Palletized vs Individual Boxes

In the world of medical device packaging, determining the worst-case scenario is a strategic process that balances risks and costs. […]

January 11, 2024

• Blog
• Industry Trends

The Tried-and-True ASTM F88 Standard Gets a Revision

As we near the close of 2023, the tried-and-true ASTM F88 standard gets a new revision. First, for those who […]

September 27, 2023

• Blog

4 Tips for Launching Your First Medical Device

It is an incredible challenge to launch a medical device, whether you are a startup or a global giant. Being […]

August 3, 2023

• Blog
• Industry Trends

PCL Team Recaps Favorite Sessions from the[PACK]out 2023

For the second year, the PCL team (Matthew TerBush, Sarah Rosenblum, and Cassie Ladd) is back with their favorite sessions. […]

June 15, 2023