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AIS Achieves ISO 13485 Certification
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Associated Imaging Services Inc. (AIS) is honored to announce that it has achieved ISO 13485 certification, according to Perry Johnson Registrars Inc.
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ISO 13485 is a sector-specific quality standard for the medical device industry. Medical devices come in close contact with patients and range from minor support for medical conditions to lifesaving capability. As such, they demand high criteria. Companies that establish and implement an ISO 13485 quality system are taking a world-class approach to the design, development, manufacture, distribution, and servicing of medical devices.
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Registration to ISO 13485 requires accountability, compliance with regulations such as the U.S. Food and Drug Administration (FDA)’s Current Good Manufacturing Practices (CGMP), maintenance of documentation, and traceability of products.
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The latest Nuclear Medicine Market research report offers crucial insights into how the industry is evolving, highlighting key drivers of growth and the main revenue streams expected between 2025 and 2032.
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Biopsies guided by high resolution ultrasound are as effective as those using MRI in diagnosing prostate cancer, an international clinical trial has shown.
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Experts from multiple medical societies have published a consensus document to provide guidance on how best to use cardiac CT for prosthetic heart valve (PHV) assessment.
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Bayer has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational contrast agent gadoquatrane for contrast-enhanced magnetic resonance imaging of the CNS and other body regions in adults and pediatric patients including term neonates.
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When is a medical device truly at the end of its life? “It depends,” according to consultant Carol Davis-Smith, MS, CCE. For healthcare technology management (HTM) professionals, that answer may be more helpful than it sounds — because it demands an informed decision. That intersection, Davis-Smith added, is the “sweet spot”; where meaningful, sustainable choices happen.
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AIS has the commitment, experience, and expertise you deserve from a service organization. We are committed to customer care and are willing to do whatever is necessary to ensure customer satisfaction. Since 1990, we have been successful in accomplishing that goal. Our service commitment has resulted in repeat business, referrals, and long-term relationships. Let AIS be the company you turn to for all your ultrasound and/or nuclear medicine needs.
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