The CES MD electrical engineering staff has the experience and capabilities to produce quality electrical designs for medical devices.   We are well versed in North American and EU safety standards, and produce a product based on designs that satisfy product requirements, ensure compliance with the applicable standards and meet your product reliability goals.

Areas of Expertise

• Digital & Analog Circuit Design
• High Gain, Low Noise Amplifiers
• Power Supplies
  • DC to DC Converters
  • Switchers
  • Low Emission Designs
  • Battery Charge and Backup
• Embedded Systems Design
• PCB Design
  • Differential and Controlled Impedance
  • High Voltage Isolation
  • Matched Trace Lengths
  • Layouts for Analog and Digital
  • Multi Layer
  • ROHS and Pb-Free Expertise
    

Tools

• Cadence/Orcad Schematic Capture
• pSpice Circuit Simulation
• Cadence Allegro PCB Layout
• Pads PCB Layout
• Visio

Our Mechanical Engineering team has vast amount of experience designing high volume and low volume plastic parts as well as sheet metal.   We compliment this expertise by extensive analytical capability to ensure the design strength is adequate for the intended application.

CES MDs mechanical engineering staff is aware of design requirements specific to medical devices including consideration for IEC 60601-1-4 safety testing, creepage distances, drop testing, safety factors, etc.

Areas of Expertise

• 3D Modeling
• Injection Molded Part Design
• Sheet Metal Part Design
• Electro-Mechanical Packaging
• Design for Manufacturability
• Design for Automation
• Custom Switch Design
• Illuminated Display Panels
• Structural Analysis - FEA
• Computational Fluid Dynamics (CFD) analysis

Tools

• ProE Wildfire
• SolidWorks
• ICE Pack
• Nastran
• Design Space
• Ansys

The software engineers in our medical division specialize in development for medical device applications and test equipment.

Our software development efforts are driven by the intended application and the outcome of the Risk Management plan and Hazard Analysis. Our software coding standards, derived from IEC 62304 (SW68), drive design and architectural requirements in accordance with the criticality class of the software.

The CES MD team has extensive design experience developing both embedded code as well as applications for medical devices. We understand critical real time functions (i.e. alarms) and have the experience working with various Real Time Operating Systems to ensure correct implementation.

Our Application expertise in areas including database development and data access through web portals has proven to be both scalable and efficient.

CES MD's architects, developers and testers provide solutions for a broad cross-section of medical disciplines with a focus on reliability, simplicity, cost efficiency, and ease of use. Our team provides high quality applications that are scalable, extensible and secure.

Areas of Expertise

• Requirements definition and specification creation
• Architecture design and engineering
• Core engineering and coding
• Feature and driver engineering
• Integration and interoperability engineering
• Tuning and performance engineering
• QA and testing
• Porting, Maintenance & Sustaining Engineering
• Embedded Real-Time Software
• PC based, C and C++ Medical Applications
• Web based, .ASP, .NET
• Database development
• API development

Tools

• MSDN development platform
• Various RTOS
• Compilers
• ICE development environments
• Crosscore development tools
• Various PIC development environments

Development of complex systems in an efficient manner requires a thorough, broad-based approach to system engineering.  We start at the System Architecture, defining architectural standards and limitations that must be adhered to by all sub-systems.   It is followed by defining interoperability requirement that will ensure seamless communication and integration between sub-systems.   Finally all input and output requirements, such as power and emission requirements, must be defined and budgeted upfront to ensure design success.

Areas of Expertise

• Architectural design
• Interoperability definition requirement
• Requirements and Specification development
  • System Requirements
  • System Architecture
  • Sub-System Requirements
  • Interface Requirements
• Design Techniques to satisfy 60601-1, ISO 14971:2007
  • Risk Analysis
  • Fault Tree Analysis
  • Failure Mode Effects Analysis (FMEA)
  • Reliability Analysis
• Standards based design for regulatory compliance

The Manufacturing Engineering team is involved in all phases of creating a product.   Our Manufacturing Engineers are responsible for developing and validating processes that ensure successful and consistent production.   This includes working with design engineers to provide input on Design for Manufacturability to selecting and qualifying the final suppliers.

Our Manufacturing Engineers are responsible for setting up a manufacturing flow based on volume; with input from the product development team in order to develop a quality build process that is easily transferable to the final manufacturer.   They are also responsible for packaging development, identifying solder chemistry issues, as well as defining and validating any special process that may be required.

The team supports Installation Qualification/Operational Qualification/Production Qualification (IQ/OQ/PQ) implementation and line validation at the manufacturing locations.

Areas of Expertise

• Design For Manufacturing
• Process Development and Verification
• Statistical Process Control
• Manufacturing Plan and Routings
• Product Assembly Structure Definition
• Supplier Technical Development

Tools

• Microsoft Office Excel
• Microsoft Office Visio
• Various CAD Systems

Our Quality Engineers have responsibility for all Quality related aspects of the project.   This includes hazard analysis activities, creating and managing the Quality Engineering deliverables, coordinating safety agency marking and regulatory compliance, ensuring Project compliance to internal and external standards, and coordinating design verification test activities.

Additionally the Quality Engineer ensures that the Design History File (DHF) content is complete and meets all ISO requirements.

Areas of Expertise

• Ensure Project Plan meets Operating Procedures, FDA Quality System Requirements (QSR), and ISO Requirements
• Leads Hazard Analysis Meeting
• Identify and document product requirements related to Safety agency and regulatory requirements
• Coordinate Safety Agency Review
• Supplier Assessment and Qualification
• Represents Quality at Material Review Board (MRB)

Tools

• Relex

Our Test Engineering team is capable of developing a complete test package starting with In Circuit Test (ICT) and board level tests through to functional system level tests.

We can help define test accuracy ratios, develop test procedures, and generate complex, fully automated test systems that are appropriate for the production volume and test time requirements.

Our Test team is also capable of supporting IQ/OQ/PQ requirements and fully supports line validation. We put our test experience and capabilities to work to ensure an effective test solution is in place.

In addition to our extensive in-house test capabilities, we have the experienced staff to assist with:

• Development of test requirements
• Development of a test plan and procedure
• Test script development & verification
• Functional test system development & build
• Analyzing test results
• Creating test reports

We can assist in the development of a product specific production test strategy, which includes a selection of:

• Automated Optical Inspection (AOI)
• Automated X-ray Inspection (AXI)
• ICT
• Flying Probe
• Environmental Stress Screening (ESS)
• Functional Test

Our full suite of failure analysis capabilities allows us to make full use of test data and provide feedback into product and process improvements.

We design and develop fully automated test racks to perform functional and final test of product on the production line. Automated test systems that we architect and design not only consider test accuracy, coverage, production volume and reliability, they also collect and provide data to satisfy the Design History File (DHF) requirements.

Areas of Expertise

• Automated Test Equipment (ATE) Development
• Development of Testable Requirements
• Product Definition for Testability and Manufacturability
• Board Level Test Development
• System Level Test Development
• Functional Testing
• Evaluation of Equipment for Testing
• LabVIEW and LabWindows™ /CVI Development

CES MD Project Managers are the focal point of the team.   They oversee complex medical device projects and lead the team of professional staff across multiple functional areas to perform to their maximum potential.

From the start of a project, the CES MD team works closely with the customer's team to develop a project plan, schedule, and detailed product requirement specifications, which are used to guide the development efforts throughout the project.

The Project Manager assures appropriate and sufficient resources are in place for every phase of the project ensuring progress consistent with the published schedule.   CES MD uses a phased development approach which includes Feasibility, Planning, Design, Clinical builds, and Design Transfer phases as appropriate.

A phased approach and the required technical and executive reviews ensure the overall effectiveness of the project during each phase. The project manager updates the plan and schedule based on feedback from phase ending reviews.

The project manager ensures that all design reviews take place as required. The Product Requirement Specification is updated with all reviews feedback, to ensure the design is meeting specification in compliance with all applicable regulatory and Safety Agency requirements.

Areas of Expertise

• Identifying Cost Risks
• Identifying Schedule Risks
• Project Tracking Tools
• Issue Tracking Tools
• Weekly Status Meetings and Reports
• Milestone Reviews
• Executive Reviews
• Communication in all directions

Tools

• MS Project
• MS Office
• TestTrack