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.
Specialties
Auditing to ISO 13485 & U.S. FDA QSR, Installing Quality Management System, US FDA 510(k) Clearance
