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Clear SOUP and COTS Software for Medical Device Development

In many industries, manufacturers have reduced development times by using COTS (commercial-off-the-shelf) software and hardware. Pressures to bring new, feature-rich products to market quickly affect medical device manufacturers as much as anyone, but the industry may be reluctant to follow suit due to well-justified concerns that COTS implies SOUP (software of uncertain provenance), and thus may compromise device safety and pre-market approval by the FDA and other regulatory agencies.
 

Fiber Laser Welding of
High Integrity
Implantable Medical Devices

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Medical implantable devices like pacemakers, ICDs and leads are progressively becoming more compact and lighter. Some of the components used for hermetic and structural welding are still large and thick enough for conventional Nd:YAG pulsed lasers. However, some of the welded components, particularly used for electrical connections, have become so small and thin that the conventional Nd:YAG laser performs like a big and rough tool. Properly selected laser beam characteristics, such as diameter of the beam and energy distribution within the focused spot in welding area, may significantly improve welding process increasing yield during production.

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