May 2026· By Jim Kasic
ISO 11607 Packaging Validation: What Medical Device Companies Actually Get Wrong
The most common ISO 11607-1 and ISO 11607-2 packaging validation mistakes — and how to avoid them on your next submission.
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Articles and guides on ISO 11607 packaging validation, sterile barrier testing, accelerated aging, and distribution simulation for medical device manufacturers.
May 2026· By Jim Kasic
ISTA 3A vs. ASTM D4169: Which Distribution Test Does Your Medical Device Package Need?
A practical comparison of ISTA 3A and ASTM D4169 distribution simulation for medical device packaging validation.
Read article →May 2026· By Jim Kasic
ASTM F1980 Accelerated Aging: The Math Behind Your Shelf Life Claim
How the Arrhenius equation, Q10 factors, and 55°C aging chambers actually translate into a defensible shelf-life claim for your sterile medical device.
Read article →May 2026· By Jim Kasic
Packaging Design for Sterile Medical Devices: 7 Decisions That Determine Your Validation Cost
Seven early packaging design decisions — material, geometry, sealer, configuration — that drive validation cost more than any other factor.
Read article →May 2026· By Jim Kasic
What Does Medical Device Packaging Validation Actually Cost?
A transparent breakdown of medical device packaging validation costs: protocol development, test execution, aging, distribution, and reporting.
Read article →May 2026· By Jim Kasic
Seal Strength, Burst Testing, and Visual Inspection: Understanding Your Sterile Barrier Integrity Test Battery
ASTM F88, F1140, F1929, F2096, and F1886 — what each test measures, when to run them, and how they fit together in an ISO 11607 validation.
Read article →May 2026· By Jim Kasic
When to Involve Your Package Testing Lab: The Right Answer Might Surprise You
Most medical device companies bring in a package testing lab too late. Here is when to actually engage — and why earlier is cheaper.
Read article →May 2026· By Jim Kasic
Medical Device Packaging Validation: Building the DHF Chapter Your Auditor Will Actually Like
How to structure the packaging validation chapter of your Design History File so 510(k) reviewers and Notified Body auditors find what they need.
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Our published guides cover the framework. For a validation program scoped to your device, packaging, and shelf-life claim, talk to our team directly.
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