Who we are
Principals, Bob Benkowski and Gino Morello each have 25 years’ experience in medical device design, development, regulatory standards and compliance, manufacturing and commercialization. Combined, they have more than 50 patents both in the US and Internationally. Their medical device experience ranges from extracorporeal and implanted blood pumps, control systems, physiologic algorithms and closed loop control, cell and web based remote monitoring, primary and rechargeable smart battery packs and smart battery chargers, electrical bone growth stimulators, in vitro medical devices and neurologic stimulators.
What we do
DesignPlex Biomedical provides the path to help you from innovation to commercialization for new medical devices. We take your idea or prototypes, carry them through a formal design development process, to regulatory approval and ready for commercialization.
Our ISO 13485 compliant development process includes:
- Mechanical design
- Risk analysis per ISO 14971
- Rapid prototyping and feasibility
- Software Development per IEC 62304
- Verification and validation
- Project/program management
- Web based, real-time remote monitoring
- Electronic circuit and PCB design
- Human Factors engineering per ISO 62366
- Specification generation
- Commercial manufacturing documentation
- Vendor selection and qualification
- Motion control and embedded systems
- LiIon, Li-Poly, NiMH and LiSO2 Battery packs, charging and fuel gauging
Our team can then help guide you for high volume scale-up, necessary approvals for international markets, and distribution/logistics in the US, EU, Japan and China.
Fort Worth, Texas
Specialties at this site include mechanical design and testing, prototyping, and future home of an ISO 7 clean room for commercial manufacturing.
Fort Lee, New Jersey
Adjacent to the George Washington Bridge connecting New Jersey to Manhattan. Specialties at this site include electronic design, software development, electronics assembly and testing.