Regulatory & Quality

Medical device experts advise focusing on quality at every stage.

FDA approved Medtronic's rechargeable device to deliver sacral neuromodulation therapy for the treatment of overactive bladder, fecal incontinence, and non-obstructive urinary retention.

The Medical Device Innovation Consortium is seeking manufacturers to participate in a new pilot study intended to help manufacturers who have had trouble achieving and sustaining quality compliance.

The Peachtree Corners, GA-based company said it submitted its protocol to FDA for a clinical study to support the marketing of the LuViva Advanced Cervical Scan.

A coherent QA strategy with clearly defined resource allocation will make healthcare solutions meet the highest standards in terms of usability, security, and interoperability.

Paperless device history records could streamline operations and readily capture data, easing access anytime, anywhere.

End-user surveys offer a cost-effective approach for assembling evidence for post-market clinical follow-up.