SERVICES
See how our expertise can bring success to your product or service.
Interim Executive
Due Diligence
Thinking about making a big investment, buying a company or starting a business? Let us help you evaluate the risks: Financial, Technical, Execution and Market Risks. Using our broad experience, we can be a force multiplier for your busy investment staff by doing much of the ground work needed to accurately evaluate interesting investment opportunities.
Regulatory
FDA Regulation is recognized as a key risk area for any company that is manufacturing or developing a medical product. Our experience includes: FDA 510(k), FDA PMA, CE Mark, EMI/EMC compliance to IEC 60601-2, Quality System compliance with GMP/ISO 13485, Bio-compatibility testing, and MDR systems.
Engineering/Prototyping
Our world class engineering and prototyping capabilities include :
- Mechanical Design ( Solidworks, CNC, 3D Printing)
- Electronics ( Digital Image Processing, Low Noise Detectors, Pulsed Lasers, Microprocessor control and User Interface)
- Optical( Optical Design, Imaging, Spectroscopy, Manufacturing, Alignment and Test Fixtures)
- Software( DSP, Windows, Assembler, Database)
- Model Shop
Our facility is capable of developing one off and low volume research prototypes. We will also work with the Global Center for Medical Innovation and T3 for more complex projects that need additional resources.