Success Stories
Custom Development
Our first custom development project has a huge success. One of our medical device customers needed a module to track the results of their proprietary testing process involving diagnostic assays and biopharmaceuticals, with a focus on orthopaedic and neurological clinical applications. Within four weeks they had the data entry and reporting capability they needed to deliver their final product.
Here is what their CEO said in his testimonial at www.captera.com:
“We are currently using it (The Lean Machine) to manage our clinical diagnostic lab, and with the help of David Smithstein, have been able to customize the system’s function to allow us to manage our entire production process from ordering materials, through generating work orders, to managing all quality documentation, to tracking inventory and WIP, through to managing incoming patient specimens and all the way to sending patient test results, all within the Lean Machine system. There is not a product for GMP or GLP document and manufacturing control that compares to the Lean Machine in capabilities at such an incredibly affordable price.”
More Successful ISO and other Certifications
Congratulations to the following companies who have used The Lean Machine™ to
certify their quality system either to an ISO family standards, or to comply
with the FDA or FAA regulations for their industry.
- Titan Dynamics - ISO 9001
- Oceana Sensors – ISO 9001
- ADTEC II – ISO 9001
- Phoenix Medical Devices - ISO 13485
- MDA Federal – ISO 9001
- Alabama Aerospace - ISO 9001
- Apollo Endosurgery - FDA 510(K)
- InspecTech AeroServices – FAA
- Kurt Manufacturing – ISO 9001
- OphthalMed LLC - ISO 9001, ISO 13485, CE Marking
- Danville Materials – ISO 13485
Certification Statistics using The Lean Machine™
Of all the companies who have attempted ISO registration using The Lean Machine… 100% have succeeded on the first attempt!
