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TYRX, a Medtronic subsidiary and developer of absorbable antibacterial envelopes, received an FDA warning letter for issues with CAPA investigations and change controls. Read More
Having a risk tool to determine what situations require corrective and preventive actions is one strategy devicemakers can use to avoid repeat CAPAs. Read More
The World Health Organization has published a model regulatory guidance for medical devices and IVDs intended to support developing nations that have yet to develop regulations covering medical devices. Read More
Renovis Surgical Technologies received a strong warning from the FDA over its failure to conform to quality system regulations covering design verification, process validation, product development requirements and risk analysis. Read More