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Quality Improvement & Process Improvement

Quality and process improvement are a key part of building a medical device or 

QMS Implementation

We have implemented Quality Management Systems (QMS) in both large and small companies.  We first document each of the processes in flow charts and then work with the business leadership to put in place a QMS that will work for the organization and will be compliant at the same time.  

Value Stream Mapping

Have you ever considered all of the improvements that need to happen inside of your organization?  We help companies create a current state and future state VSM.  

Change Management

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Design Controls

The FDA requires that companies have a documented phase-controlled process for designing products.  We have implemented design control programs inside of organizations large and small.

Process Improvement

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Risk Management

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What Our Clients Say

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