You have found the consulting firm that is here to help you get your product to market and keep it there.
We provide expert guidance in world-wide Quality Management Systems, Risk Management and Regulatory Compliance to allow business leaders & entrepreneurs to focus on their strengths.
We specialize in creation, audit and remediation of Quality Management Systems including Design History Files and other documented information to support manufacturing organizations and regulatory submissions for medical device companies.
We hope we can help you formulate an effective strategy to create a quality management system that meets your needs. While we focus on Medical Device Quality Management Systems (ISO 13485), including dealing with US FDA under 21CFR, we also provide guidance in General Business Quality Systems (ISO 9001). We can help you in other ways as well. Please see our services page for a full menu of services
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