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The FDA slapped medical device manufacturer XZeal Technologies with a Form 483, citing issues with reporting procedures and design validation. Read More
The FDA sent Canada-based Savaria Concord Lifts a warning letter citing twelve violations regarding corrective and preventive actions (CAPAs), complaint evaluations, software validation, and other areas. Read More
Rapid Release Technologies received a warning letter for failing to apply for premarket approval (PMA) or an investigational device exemption (IDE) for a massage device. Read More
Germany’s Biotronik received a warning letter for inadequate process validation procedures, supplier selection procedures, and other violations. Read More
FDA inspectors observed various problems at a Narishige medical device facility in Tokyo, including inadequate design control procedures and other violations. Read More
Advanced Breath Diagnostics was hit with a Form 483 citing 11 observations related to corrective and preventive actions (CAPA), rework and reevaluation activities, acceptance procedures, and other areas. Read More
Grace Fu Palma, founder and CEO of Boston-based China Med Device, a firm specializing in commercialization and funding for medtech companies entering China, explains how medtech companies can use a new guideline from the China FDA to help secure fast track approvals for innovative medical devices.Read More