About
Quality and Regulatory Compliance Services for Medical Device Firms. With 35 years of medical device industry experience we provide cost effective pathways to compliance by: • Installing Quality Management Systems (QMS) that conform to ISO 13485 and U.S. FDA medical device regulations. • Preparing and Shepherding 510(k) submission to approval. • Conducting Internal and Supplier Audits in accordance with ISO 13485 and FDA quality system regulations, RAB/QSA certified training. Our low overhead and narrowly focused business model allows us to deliver high quality consulting services at an affordable price, 100% Client Satisfaction Guaranteed.
Technologies
Cloudflare DNS
Remote
Keywords
auditing to iso 13485 amp us fda qsr
us fda 510 clearance
installing quality management system
auditing to iso 13485 us fda qsr
medical equipment manufacturing
medical devices
hospital & health care
Company Information
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Employees 1
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Founded 2004
Location
1289 Fordham Blvd, Chapel Hill, North Carolina, United States, 27514
