Category: ISO Certification

ivWatch Receives CE Mark and ISO 13485:2016 Certification

In addition to conforming to European standards as signified by the CE mark, the company also announced that it has obtained ISO 13485:2016 certification through the Medical Device Single Audit Program, a global standard for medical device quality management systems.

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FOBI Medical Attains ISO 13485:2016 Certification

Tomball, Texas-based FOBI Medical, FiberOptic Bulbs (FOBI) announced that it has received International Standardization Organization’s ISO 13485:2016 certification, indicating the company’s quality management system for medical lamps and fiber optic cables adheres to stringent requirements.

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Cultivating a Culture of Quality: Rick Lytle

In late November, Milwaukee-based Alpha Source acquired BC Technical, doubling the size of the former company. Here, Alpha Source CEO Rick Lytle discusses what the merger means for the healthcare industry and advises HTM professionals about what to look for when selecting a service provider.

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Sage Services Group Scores ISO Certification

Sage Services Group, based in Charleston, S.C., has received dual certification to ISO 9001 and ISO 13485 standards for its quality management system. ISO 9001 is the world’s most recognized quality standard, while ISO 13485 specifies requirements for an organization’s ability to meet customer and regulatory requirements applicable to medical devices and related services.

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