Greycat Quality provides a range of Quality Assurance, Quality Engineering and Quality Consulting services to developers and manufacturers of medical devices and combination products. We offer QA engineering support for most quality assurance tasks as well as a comprehensive design control consultancy, providing strategic guidance to support your future growth or quality transition.
We specialize in design quality engineering, quality management systems, risk assessment and reliability engineering. Our associates have experience dealing directly with US FDA and notified bodies, sometimes in difficult situations, yet we remain pragmatic, recognizing that a business needs to function with efficiency and productivity while still maintaining regulatory compliance.
Our experience includes products in development, small-scale batch produced products, large integrated systems and volume manufactured devices. We serve all types of client from start-up companies to blue-chip corporations and can support needs from as little as a few hours to full-time on-site deployments.
Email us at [email protected]
Company’s Keywords:
safety risk management, fda form 483, combination products, design for reliability, iso 14971, reliability assurance, dhf remediation, reliability analysis, quality system regulation, capa, quality management systems, us food & drug administration, design history file, iso 13485, fda warning letters, 21cfr820, medical device
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