FDA Compliance Help

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.

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