Who we are
Bob Benkowski and his team has over 25 years’ experience in medical device design, development, regulatory standards and compliance, manufacturing and commercialization. He has numerous patents both in the US and Internationally. Our 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, in vitro medical devices, neurologic stimulators, and biologics.
What we do
DesignPlex Biomedical provides the path to help you from innovation to commercialization for new medical devices. We take your idea and create prototypes. We take prototypes and carry them through a formal design development process, to regulatory approval and ready for commercialization.
Our ISO 13485 compliant development process includes:
- Mechanical and electro-mechanical design
- Risk analysis per ISO 14971
- Rapid prototyping and feasibility
- Software Development per IEC 62304
- Verification and validation
- Project/program management
- 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.
Our location
Fort Worth, Texas
At the crossroads of medical, aerospace, and energy, North Texas is the ideal location for high tech medical device device development. This includes mechanical, electro-mechanical, and electrical design; prototyping, testing, marketing, and the future home of an ISO 7 clean room for medical device manufacturing.