Safety and Compliance in Micro-Endoscope Manufacturing

Endoscopes and other visualization systems are a core part of enabling innovative medical procedures. The FDA rightly views visualization systems as medically critical technology, designed to enter normally sterile environments, tissues, or vasculature structures. Given this, the FDA requires that endoscope manufacturers follow the most stringent Quality System/Good Manufacturing Practice (QS/GMP) requirements, in areas including:

Cradle-to-grave documentation, from product design through post-market surveillance
Cradle-to-grave review, audit, and verification procedures
Cradle-to-grave quality assurance process controls
Extensive standards for cleanliness and sterilization

BioVision Technologies fully meets or exceeds all FDA QS/GMP requirements for endoscope manufacturers for rigid, semi-rigid, and flexible endoscopes. Our quality assurance, documentation, and verification systems are regularly audited by outside experts, both those we engage and those engaged by our strategic partners as part of their own FDA compliance. We also engage outside experts to audit all our global manufacturing affiliates which supply assembled components. [Dave: add, or link to websites for any of the outside agencies we work with?]

Our autoclavable endoscopes have been tested for sterility and effectiveness at upwards of 50 cycles of re-use, and our disposable endoscopes meet or exceed all FDA standards for sterilization procedures.

Visualizing better care today; enabling the procedures of tomorrow

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