An overview of Sunrise Labs, a medical device and instrumentation product development firm.

1. Celebrating 20 years of turning client ideas into award winning products!
12/5/2012 – Sunrise Confidential 1

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)
12/5/2012 – Sunrise Confidential 6

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
12/5/2012- Sunrise Confidential 9

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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