S&A provides biomedical engineering pre-production and production prototype development for medical devices. Our services include the design, development, test, and evaluation of microprocessor-controlled electronic, electro-mechanical, and electro-optical devices in a manner that is completely consistent with 21 CFR 820.30, the most recent guidance from the FDA, and the state of the art in biomedical engineering.
| We will work with you to develop your user's requirements and then provide you, in an iterative process, with specifications (system, hardware, software, and ergonomics) and verification trace matrices to demonstrate correspondence to the user's requirements. |
| Once the engineering specifications and the corresponding trace matrices are approved, we will implement the design - in the most cost effective manner from a production perspective - of the hardware, of the software, of the human interfaces and generate verification trace matrices to demonstrate correspondence of the implementation to the specifications. |
| Once the implementation is approved, we will generate an overall test plan (system, hardware, software, and ergonomics), statistically-correct test cases, test jigs and the verification and validation test matrices to demonstrate that the tests prove complete verification of the engineering specifications and complete validation of the user requirements. |
| Upon approval of the test procedures, we will execute the test plan, analyze the resulting data and generate a final report that includes all FDA-required design history file documentation. |
Please look at our product development papers in our e-Library.
Dr. George Samaras is a registered Professional Engineer (MD#13006), a Certified Quality Engineer (ASQ #47597) and a Certified Professional Ergonomist (BCPE#950). He received his basic training in Electrical Engineering (BSEE) and earned doctorates in both Physiology (PhD) and Industrial Engineering (DSc); he has a number of biomedical equipment patents and an extensive list of scientific publications in biomedical research. Dr. Samaras worked for the U.S. FDA/CDRH as a scientific reviewer and as Associate Director of Electronics and Computer Science. He was the CEO of a FDA-listed biomedical engineering firm for a decade. He has conducted clinical and laboratory biomedical research, while on the faculty of a major medical school; he has been on the faculty at two major engineering graduate schools teaching technical management, project management, and ergonomics. He is a member of the NSPE, IEEE, IIE, IVT and ISPE.