Quality Assurance in the Medical Device Industry

There is a multitude of human resources, machinery, and knowledge involved in the creation of medical devices. Engineers generate the designs, line workers fabricate the product and teams prepare items for shipment. Woven throughout the process are many checks and balances put in place to ensure that quality remains the focus of production.

Engineering of Packaging

In most situations, the packaging plan of a device begins concurrently with the layout of the device. Medical package testing is carried out to determine if containers meet or exceed industry regulations. Several forms of seal verification can be performed to validate tolerances. Peel and burst testing, along with dye penetration trials provide visual and numerical evidence of durability. The peel and burst methods test seal strength in relation to pounds of pressure, and the dyeing process gives a visible confirmation that liquid cannot pass through barriers.

In-Process Investigation

As parts are moved from one workstation to the next, they must be inspected for defects. Using AQL (Accepted Quality Limit) tables, samples are scrutinized while checking for tolerance variations or physical damage. Laser etching related to the lot and part numbers is also proofread every step of the way to avoid mixed lots of similar material. If discrepancies are discovered, the entire batch may be held up indefinitely until a solution is found. In rare cases, a recall can be enacted to gather parts that have already been sent into the field which may be defective.

Final Quality Review

One of the final steps before introducing the merchandise to the marketplace is to have representatives from all departments involved with producing the device perform a final audit. Planners, engineers, quality technicians and project managers dissect everything from the regulatory wording to the structure of a piece. These sessions are necessary to establish that all procedures have been followed and that documentation is sufficient for routine FDA inquiries.

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