HOME | c6systems

Our Vision

C6 is a vertically integrated provider for the accelerated development of medical devices and healthcare services including design, development, marketing and training of new products.

Our mission is to deliver critical technologies and services for the improvement and safety regulations into all aspects of the medical, sterilization and laser safety industries while guiding you through the FDA acceptance process.

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PORTFOLIO

WHAT WE DO

01 / FDA / MEDICAL DEVICE

We offer FDA Validation Services for large and small projects. We have 16 years experience with Bio-medical and Pharmaceutical companies in validation on surgical products and medical device manufacturing test systems.

04/ EnviroDAQ

Temperature Logging Data recording systems from 1 to 100 channels. In 19" rack form-factors.

02 / START-UP / RAPID ENGINEERING DEVELOPMENT

We do 'FAST' and understand that start-ups need rapid, experienced concept, design and implementation of ideas. We have turned around computer control systems, incorporating hardware, electronics and software in a few weeks...not months.

05 / Training

Training courses for developing in regulated space. Workshops on how to develop and write system and software requirements, and validation and verification strageties with practical and real-world solutions.

03 / Optical Design

We provide optical design and modeling from napkin concepts to working prototypes.

We develop optical design for illumation, telecomm and surgical otpiomology.,

06 / ONE-OFF PROTOTYPING

Need 'one' of something?..We get that...we do that. I have prototype fabrication capability for rapid prototype creation.

SERVICES

01 / FDA MEDICAL DEVICES

We provide FDA Validations Services for Medical Devices. We specialize in rapid requirement, protocol and validation development. Additionally, we can help with establishing your Quality system, recommend standards and best industry practices to quickly establish a compliant quality system.

We specialize in:

1/ Medical Device Software Requirements and Validation

2/ Medical Device R&D Test Validation

3/ Medical Device Production Test; Methods, Requirements, and Validation

4/ Production Tool Validation Methods

Most important is to first develop a Strategy; A good strategy considers not just the Quality System, but how it actually gets implemented and maintained in a practical way. A cumbersome quality system is a common pitfall of the medical device businesses. And quite often the 'why' of how things are done gets lost in the 'how'. This can cripple an organization.

01 | FDA / MEDICAL DEVICES

02 / START-UP / RAPID ENGINEERING DEVELOPMENT

We understand how to rapidly conceive, design and build technology. We do it ourselves. We've done:

1/ Mechanical Parts handling and test fixturing

2/ Data acquisition and control systems

3/ Robotic parts handling

4/ Optical systems

5/ Optical measurement systems: Beam profiling, M^2, Power and Stability

6/ Electrical control systems; relays, power routing, DIN rail control cabinets

7/ Gas control systems [fully automated script driven Rack systems]

8/ Vision systems for assembly, test and measurement

9/ Software for Automation & Test

10/ Embedded software; ARM, FPGA, PLC and Windows based software applications

Because of our broad experience, we know the tools, and right tools for the job.

02 | START-UP / RAPID ENGINEERING DEVELOPMENT

03 / Training

Training courses for developing software in regulated space. Workshops on how to develop and write system and software requirements, and validation and verification strageties with practical and real-world solutions.

LabVIEW [Software] Development in Regulated Space

Course is to provide practical guidelines and coding techniques for developing LabVIEW code in regulated space. The course is two parts of creating software requirements [SRS] and specifications to practical and actual LabVIEW coding techniques for developing code in regulated space. The course is interactive and provides free software toolkits for coding in regulated space.

The material is divided into coding and developing requirements and test/validation protocol development, targeted for experienced LabVIEW developers and Quality engineers who have to create software requirements, but have no LabVIEW experience.

The goal of the course is for those approaching software development in LabVIEW or overseeing software development in regulated space to develop fundamental and practical understanding and skills on how to approach, develop and manage software development in regulated space.

Instructor is Jack Hamilton, of C6 Systems, Inc with 30 years experience in LabVIEW software development and FDA consulting. Mr. Hamilton has and continues to work for numerous fortune 500 medical device companies in the US, developing software and consulting in validation for medical devices.

Software Requirement Creation and Development

Experience Level 2 yrs minimum in LabVIEW

Coding Skills in Regulated Space [2 Days]

Code Architecture: Robust frameworks
Encapsulate and compartmentalize code functions for easier development and validation testing
Data acquisition and processing coding guidelines
Code configuration; storing configuration and settings, best practices
Error handling: Guidelines and error handling toolkit
Data and Settings file management techniques in the application code
Hardware configuration management in the application code
Meta tagging requirements in your LabVIEW project

Software Requirements Development 1 Day Course

LabVIEW Experience Level: None Required

How to define, develop and create software requirements. Including practical and actual wording to use to create clear, concise and testable requirements. How to think about wording and structuring requirements to streamline the development, Test and Validation process.

Unblock writers block: Concise practical instruction on how to create requirements and specification wording. Interactive instruction on how to think about and create requirement declarations. Numerous examples of actual requirements, Validation and test protocol wording as cliff notes.

Tips and Techniques for developing software requirement documents. Example template of Software Requirement Documentation. Brief overview of MSWord techniques for document formatting and requirement tracking.

Validation Test Execution [1/2 Day]

LabVIEW Experience Level: None Required

How to create Test validation protocols. Understanding of what essentially are the goals of developing and writing requirements. Actual examples in a streamlined format. How to create a clear path from the requirement on paper through code development to the final code validation testing.

Tips and Techniques for executing validation protocols. Example templates of validation protocols. Brief overview of MSWord techniques for document formatting and requirement tracking.

Contact : Zach Olson zach@ez-techstop.com [949-275-7278] for course and schedule information.

03 | Training

04 | EnviroDAQ