Sunrise is expert in product development for robust, reliable, "smart" devices and instrumentation and have deep technical expertise in project management and systems integration. We excel as a strategic engineering resource ranging from complete product development to component obsolescence, 3rd edition, RoHS/REACH compliance, SWQA, V&V, and life cycle management and are ISO-13485 certified.
1. Celebrating 20 years of turning client ideas into award winning products!
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2. O systems experts listen to
Our
our clients, define an optimal
architecture,
architecture select the most
appropriate technologies and
leverage our strategic partners
to design, b ild and d li
t d i build d deliver
products that work
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3. Who we are….
are
Incorporated - J
I t d January 1992 * E
Experienced M
i d Management T
t Team*Privately h ld
*P i t l held
Technical Innovation and Product Development for
p
Life Science,
Medical
and High-Tech Industrial product companies
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4. Development Services
Complete System Design and Requirements management
Battery and Power Architecture
Complex Analog and Digital Design
Embedded Systems
Software Development; Real-time, Multi-tasking Systems
p g y
User Interface Design and Development
Project Management ……………….Project Rescue
Verification and Validation
Risk management ISO-14971
Support for Regulatory and FDA Approvals
Prototype Fabrication and Test
ISO-9001 and ISO-13485 Certified
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5. Development Environment
Cooperative & Flexible Team Approach
Comprehensive Project Control Procedures
Project Appropriate Tools
Project Appropriate process – Waterfall, Agile, etc.
Process oriented, risk based development
Client Version / Enhancement Tracking Database
On-line collaboration tools
Compliance with Applicable Regulations and Standards
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6. Quality and Regulatory Processes
A demonstrated process driven by International Standards a d Best Practices…
de o st ated p ocess d e te at o a Sta da ds and est act ces
Understanding and negotiating Regulatory Forces and
Quality Management Systems is vital to the success of any
life sciences project:
Quality Management System
(ISO 13485)
Risk Management Process
(ISO 14791)
Software Development Lifecycle framework
of processes, methods and activities
(IEC 62304)
SOP’s
(International Standards for
Software D
S ft Development)
l t)
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7. Project Management
System design approach
Technical design experts
Quality designed in – not tested in
Incorporate client’s guidelines & templates
client s
Collaborative design environment
Client-focused teams
Weekly Communications
W kl C i ti
EINs to formally communicate project changes
Deliver projects on-time & within budget
Consistently exceed expectations
Risk mitigation based planning
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8. Technical Expertise
System Architecture Design Algorithm Development
Medical Electronics Embedded Software
Instrumentation & Control Display / LCD
Single Board Computers DSP
Embedded Microprocessors
E b dd d Mi UI and GUI Development
d D l t
Modeling & Simulation Image Processing
Analog Signal Detection & Electro-optical
Control Windows , Mac OS
Power Electronics RTOS
Robotics Linux Embedded
CanBus, ModBus, etc. Win CE / Net
Ethernet Embedded XP/Win7
Electro-mechanical C, C++, C#, OO, Assembly…
Wireless Connectivity PLD / FPGA
SWQA,
SWQA Risk Management PCB D i
Design
RFID Design for Manufacturing
Regulatory Compliance Mobile Development (iOS, Android)
IEC 60601-1, IEC 62304 Serial Communications , USB etc
USB, etc.
21 CFR 11, 21 CFR 820.30
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9. Sunrise Labs Advantage
Delight Your Company & Your Customers
Leverage Sunrise Experts
Apply a Proven and Comprehensive Development Process
Smooth Transition from Design to Manufacturing
Transform Your Bright Ideas into Award winning Products
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10. www.sunriselabs.com
Please visit our website for case studies and more information, or call us to learn more:
603-644-4500
Look forward t hearing f
L kf d to h i from you. Th k you!
Thank !
2009-09-14
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