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 / EnviroRack

Test part fixturing solutions for environmental temperature testing. Proving easy access, sliding trays for quick sample loading. Options include electrical signals and pressure routing and cable management.

03 / 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.

06 / ONE-OFF PROTOTYPING

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

 

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.

 

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.

 

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.

 

04 / EnviroDAQ

 

Self contained temperature acquisition and data logging systems for environmental testing.

Windows based data acqusition from 1 - 100 channels in 19" rack or stand-alone. NIST traceable certification options and ultra low cost options avaliable.

  • Windows10 PC Based

  • National Instruments acquisition hardware

  • Open API architecture

  • Network based data display and publishing

  • Integrated Compact Touchsceen Display/Interface

  • Email and SMS messaging notifications

  • Customizable

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

05 / EnviroRACK

 

We offer rapid design and development of Environmental Testing racks. Combining a flexable modular rack system with custom design tooling for rapid loading and testing in production and high-volume/part count applications.

The EnviroRACK can fit in your existing environmental chamber providing sliding shelves to optimize parts handling. This results in faster parts handling/load time and more consistent testing.

EnviroRACK options include cable managment for electrical and pressure/vacuum/fluids for those applications where these stimuli in conjunction with temperature is required.

06 / ONE-OFF PROTOTYPING

 

Coming Soon!. We are expanding our rapid engineering build capability directly to our customers!.

CLIENTS

The trademarks and logo's listed herein are property of their respective owners/companies.

 

CONTACT US

 
LINKS
ABOUT

Zach Olson 

zach@ez-techstop.com

[949-275-7278] 

info@c6systems.com

Tel: 714-496-4130

9277 Research Drive 

Irvine, CA 92618

USA

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