Company Overview & Capabilities

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1 Company Overview & Capabilities

2 Company Overview Mission Statement "The Mission of is to provide expert technical resources to our partners in order to develop concise and timely strategic solutions based on value and integrity" is a comprehensive product development consultant firm with an emphasis on embedded electronics and software development. The company was founded with the philosophy of providing expert, cutting edge services from ideation through production. The Core Values that define the character of Pentad Design and its people are Knowledge, Experience, Leadership, Discipline, Teamwork, Customer Service, and Integrity. Through these guiding principles, Pentad Design has successfully improved the time to market for its clients. The founders of Pentad Design have a combined 70 years of expertise in the product development consultant industry. Pentad Design understands the evolving development environment and continues to create methods to streamline the development cycle. Expertise In: -Rapid Software Development -Successful Production Designs -Medical Devices, Consumer, Commercial and Industrial Products -Texas Instruments Third Party MSP430 & DSP Partner - Freescale Third Party Network Partner Contact Information:, Orange County, California, USA Contact: Aaron London, Phone: (714)

3 Mechanical Engineering & Industrial Design Capabilities Class I, II, III Medical Devices Consumer, Commercial & Industrial Products Overview of Mechanical Engineering Services CAD Surface and Solid Modeling Technology Assessment Process Based Engineering Mechanism Design Rapid Prototyping Proof of Concept Manufacturing Engineering (DFMA) Breadboard Development Vendor Liaison Electromechanical Integration Overview of Industrial Design Services Strategic Product Planning Conceptual Development - Evolution and Innovation 3D Modeling / Product Renderings Mockups Models Functional Models Usability-Engineering Process and Compliance o Usability Risk Analysis o Operator-Device Interface Ergonomic Studies Competitor Product Analysis Market Study for Product Placement User / Environment Analysis Focus Group Research Consumer Research

4 Electronic and Software Engineering Capabilities Overview of Electronic Engineering Services System Architecture Hardware/Software Partitioning Class I, II, III Medical Devices Special Safety Systems for Safety Critical Devices Industrial, Scientific, and Consumer Electronics Programmable Logic FPGA, CPLD Battery Powered / Portable Products Electro-optics Motion Systems Overview of Software Engineering Services Embedded Systems: Class I, II, III Medical Devices Commercial and Consumer Products Battery Powered Products Power Management 8 / 16 / 32 Bit Processors RISC / ARM / DSP processors Language Support (C, C++, Assembly) Legacy Language Support OS Custom, Off-the-Shelf Peripherals Comprehensive Expertise Windows Applications: MFC C++ Builder Debug Test Applications Production Support Applications

5 Regulatory and Agency Compliance Design Control: 21 CFR Part 820 (Quality System Regulation) 21 CFR Part 11 (Electronic Records/Signatures) ISO 9001:2000 (Quality Management Systems) ISO 13485:2003 (Medical Device Quality Management Systems) ISO/IEC 12207:1995, 2002 (Information Technology Software Life Cycle Processes) IEC : 2000 (Medical Device Software Life Cycle / Risk Management) IEC (Medical Device: General Safety Requirements / Usability) ANSI/AAMI SW68: 2001 (Medical Device Software Life Cycle Processes) Product Safety: Medical Devices Commercial Products Instrumentation Consumer Products Information Technology Devices Classified / Hazardous Environments EMC: FCC, FDA, EU Emissions Immunity QSR Compliance: Design Control Risk Management / Mitigation (Hazard Analysis, Fault Tree, FMECA) Verification Validation EU Compliance: Medical Device Directive ISO 13485:2003 (Medical Device Quality Management Systems) ISO 14971:2000, 2003 (Medical Device Risk Management) FDA Premarket Submission: IDE PMA 510(k)

6 Expanded Electronic Engineering Services Class I, II, III Medical Devices: Ventilators (ICU, Sub-acute, Home Care) Respiratory Monitoring In-Vitro Diagnostics Dental Diagnostics Smoke Evacuators Drug Delivery Disposable and Reusable Electronics Special Safety Systems for Safety Critical Devices: Watchdog Signature Register Fail Safe Intrinsically Safe Industrial, Scientific, and Consumer Electronics: Electrochemical Analyzers Internet Appliances Spectrophotometers Cameras RF ID Electro-optics: Displays, Backlights Fiber Optics IR Motion Systems: Brushless Microstep

7 Expanded Software Engineering Services Class I, II, III Medical Devices: Ventilators Blood Analyzers Infusion Pumps Dental Diagnostic Tools Commercial and Consumer Products: Digital Photo Plotters High Performance Data Acquisition Cell Phone Accessories Legacy Languages: PASCAL ALGOL PL/I PL/M COBOL Fortran OS Custom, Off-the-Shelf : Custom, Including Real-time Preemptive, Multi-tasking Peripherals: SPI LCD I 2 C Bitmap Graphics ADC LED DAC Multi Port RAM EEPROM Hardware FIFO Asynchronous serial Keypads Parallel I/O Beepers One-Wire Buzzers Real Time Clock Digital Audio Watchdog Custom Devices Comprehensive Expertise: Remote Firmware Upgrades Floating-point Math Routines Motion control FFT JTAG GUI User Interface Software Digital Filter Keypad Scanning and Debounce PWM Control Closed and Open Loop Control Serial and Network Protocols Direct Frequency Hopping/Spread Spectrum Target Hardware Simulation for Rapid Prototyping

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