Info for government contracts
Devicix, LLC is a multi-disciplinary engineering firm based in Minnesota that focuses on the design and development of medical devices. We also develop devices and instrumentation that translate research into reality. We have a complete staff of electrical, mechanical, biomedical and software engineers to support product development programs. Devicix has created Class I, II and III medical devices for numerous medical specialties. Our core competencies include electrical design, mechanical design, software design, product development, project management, process development and scale-up for manufacturing, regulatory support, quality assurance, and intellectual property support. We are very experienced with commercialization, concept generation, rapid prototype development, and proof of concept determination. We have taken ideas from the back of a napkin to a human-use medical device. We strive to understand what our clients' objectives are, and then determine the best way to go about achieving them.- Limited Liability Corporation, MN, 2004
- Privately held
- DUNS Number: 187664292
- CAGE Code: 48X83
- Small Business
- CCR registered
- ORCA registered
- Certified in ISO 13485:2003 (quality systems for medical devices) and 14971:2007 (risk management for medical devices)
- Registered with FDA for quality system regulation (21 CFR 820)
- Registered with FDA as medical device manufacturer (21 CFR 808, 812 and 820)
- NAICS codes: 541711 (primary), 541712 (primary), 541330 (primary), 541511, 541340, 541380, 541420, 541990, 541690
Capabilities
Mechanical design
- Development of design inputs, requirements and specifications
- Implant development including cardiology and orthopaedic devices
- Electromechanical packaging and design
- Catheter designs for therapy and device delivery
- Closed and open loop motion control systems
- ISO 13485 and 14971-certified design controls including phase gate product development process
- Finite element analysis and computational fluid dynamics analysis
- Rapid prototyping
- Final design, refinement and verification services for prototypes or existing devices
- Complete verification and validation testing from design, sterilization, and packaging to system validation including cadaver, animal and human clinical
- Structural, packaging or marketing design
- Human factors engineering including device and computer user interfaces, ergonomic and ease of use analyses, and regulatory compliance (FDA/IEC/OSHA)
- Biocompatibility issues including toxicity and sterilization
- Risk assessments including hazard analyses and design failure modes and effects analysis
- Material selection for device's anticipated life span, mechanical and physical environment, and cost
Electrical design
- International electrical safety standards for medical systems and equipment - EN/IEC 60601-1 CSA, JIS, MIC equivalent
- Microprocessor/microcontroller design, including embedded applications, for diagnostic, external and implantable medical products using CAD packages like PADS
- Design of open and closed systems interfacing motors, sensors and memory to provide products on any platform level
- Field programmable gate arrays
- Digital signaling processing
- Wireless technology
- Sensor design
- Protocol & communication development
Software design
- Software risk management according to ISO 14971
- IEC 62304 standard for developing medical device software
- Software design history file remediation to meet FDA or 62304 standards
- Embedded and real-time software
- User interface development
- Desktop applications
- Troubleshooting and enhancement of existing software
- Software verification and validation
Process development and manufacturing
- Vendor identification/qualification
- Materials procurement
- Incoming inspection work instructions
- Incoming materials inspections/records
- Manufacturing work instructions/records
- Process development and validation
- In-process testing and verification
- Bill of materials management
- Process failure modes and effects analysis
- Clean manufacturing
- Final product inspection/release
- Labeling
Quality assurance
- 21 CFR 820 Quality System compliance
- ISO 13485:2003 Quality System compliance
- ISO 14971:2007 Risk Management compliance
- Regulatory compliance GAP assessment
- Quality system development and implementation
- Regulatory strategy and guidance
- PMA and 501(k) regulatory submission
- Clinical trial management
- Policies and procedures implementation
Risk Management
- Total product life cycle
- Risk management planning
- Clinical effects analysis
- Fault tree analysis
- Design failure mode effects analysis
- Process failure mode effects analysis
- Risk management reporting
Relevant Codes
NAICS Codes
- 541711 R&D in biotechnology (primary)
- 541712 R&D in physical, engineering, and life sciences (primary)
- 541330 Engineering services (primary)
- 541511 Custom computer programming services
- 541340 Drafting services
- 541380 Testing laboratories
- 541420 Industrial design services
- 541990 All other professional, scientific, and technical services
- 541690 Other scientific and technical consulting services
Product Service Codes
- AN10 R&D Biomedical
- AN40 R&D Health services
- AN60 R&D Medical rehabilitation engineering
- AN70 R&D Specialized medical services
- AN90 R&D Other medical
- AD20 R&D Services
- AE20 R&D Product/services improvement
- AJ50 R&D Life sciences
- R414 Systems engineering services
- R425 Engineering & technical services
Federal Supply Codes
- 6515 Medical, Dental, and Veterinary Equipment and Supplies - Medical & surgical instruments, equipment and supplies
For more information, please contact:
William D. Lew, MSDirector of Research
Main: 952-368-0073
Direct: 952-905-2881
Mobile: 952-905-6124
Email: blew@devicix.com
