The Part Failed. What Evidence Should You Preserve First?
Do not clean, polish or repeatedly refit a broken part before deciding what evidence must be preserved. Medical device failure analysis begins with a controlled description of the event and…
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Do not clean, polish or repeatedly refit a broken part before deciding what evidence must be preserved. Medical device failure analysis begins with a controlled description of the event and…
A part can pass dimensional inspection and still puncture a pouch or work loose in a protective tray during transport. Medical device packaging validation therefore cannot be separated from the…
One sample returning a favorable result does not establish that a production sterilization process is validated. Medical device sterilization validation requires an appropriate, documented demonstration for the specified product and…
The sterilization route should be considered before a device’s material and assembly decisions become expensive to change. Heat, moisture, radiation and chemical exposure can affect a component differently from normal…
A polished component can still carry machining fluid inside a blind hole. A molded housing can arrive free of visible dust but retain processing residue at a joint. Medical device…
Small does not automatically mean difficult to mold. A tiny connector with generous radii may be straightforward, while a larger diagnostic cartridge can contain channels that are difficult to fill,…
The wrong make-or-buy decision can trap capital in underused equipment or place a critical process behind a supplier boundary the team cannot manage. Medical device contract manufacturing vs in-house production…
The cheapest unit quote is often not the lowest-cost route. It may exclude tooling changes, validation, inspection fixtures, documentation, yield loss, supplier management, packaging, or the engineering needed to make…
Imagine a complaint arrives with one device identifier and no intact packaging. Can the team determine the material lots, drawing revision, operators, machines, special processes, inspection results, software or label…
A supplier may describe a resin or alloy as biocompatible, but that label does not approve a finished device. Biological safety depends on the exact material, additives, colorants, manufacturing route,…