Case Studies: Case Studies – Medical Devices

Raw Material Specification Changes Resolve Problem with Cured Silicone

Silicone elastomers, foams, coatings, and adhesives are widely used in virtually all aspects of manufacturing, in construction, the automotive industry, and medical and personal care products. The properties that contribute to making silicones indispensable in many applications, such as their ability to repel water, their excellent heat stability and chemical resistance, are also responsible for ...
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Outsourced Component Did Not Contribute to Medical Device Implant Failure

When the manufacturer of a medical device implant saw an increase in the device’s failure rate after implant, they alleged that a component provided by a supplier was responsible.
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Maintaining FDA Approval: Substitute Material

RJ Lee Group helped a client demonstrate that a change in source materials would not affect patient safety or product performance. Ongoing FDA approval was granted without the need for costly re-resting and re-submission.
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Failure Analysis Investigation Points to QC Solution to Maintain Profits and Customers

Shatter-prone glass syringes pose any number of risks — to patients and health care workers — and costly, potentially dangerous waste. One well-known medical device manufacturer wanted reliable data on why syringes from an overseas manufacturer would shatter upon loading.
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