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Fort Worth, Tex.-based Sanara MedTech has high hopes for a promising wound imaging device and a companion biomarker assay it is gaining as part of its $5.1 million purchase of Precision Healing of Newton, Mass. Read More
Establishing a classification system for complaints helps organize your analysis. Quality expert Dan O’Leary of Ombu Enterprises recommends classifying complaints by type of failure. The real issue, he says, is that “a complaint alleges a deficiency.” The customer is complaining the device is deficient in meeting one or more essential design output areas, such as: identity; quality; durability; reliability; safety; effectiveness; and performance. Read More
Durham, N.C.-based Bioventus is buying CartiHeal and its Agili-C implant for knee-joint cartilage surface lesions, a breakthrough device which recently received the FDA’s premarket approval. Read More
Equipment adjustment is an important part of Quality System Regulation-compliant operations. Under §820.70(g)(3): “Each manufacturer shall ensure that any inherent limitations or allowable tolerances are visibly posted on or near equipment requiring periodic adjustments or are readily available to personnel performing these adjustments.” Read More
Information about leveraging validation data to support COVID-19 test approvals has now been added to the FDA’s COVID-19 Test Development and Review FAQ page. Read More
Several advocacy groups have written to the House Energy and Commerce Committee and its Subcommittee on Health to defend the “right to repair” devices and push back against what they view as moves to restrict it. Read More