Class 3 Medical Device – ISO 13485/FDA 21 CFR 820

Creation of automated test systems for new group of products under contract to the engineering division of a fortune 500 company.

Specifics: Off-site Agile Project Center synchronously developing unit, system and functional testing of customer developed software modules.

Services Provided:

  • Off site project based verification and validation services.
  • Program Management
  • Technical Management
  • Hardware Engineering
  • Process Creation
  • Custom Test fixture Development and associated Software

Results: Reduced clients formal test runs from 2 months to 48 hours

Other services and activities: Performed all training and staffing to achieve project resourcing needs for 25 software and hardware engineers.

 

Class 3 Medical Device – ISO 13485/FDA 21 CFR 820

Developed automated testing system for complete testing of 14 Systems including a physician Programmer, Patient Programmer and implantable CLASS III medical devices including Neurostimulation and Drug Pumps to provide Therapy for  Advanced Parkinson’s Disease, Essential Tremor, and Dystonia

 

Class 3 Medical Device – ISO 13485/FDA 21 CFR 820

Performed Verification services for Patient Bedside Monitor. Scope included end to end verification of all aspects of a patient care system from doctor and patient websites to the implanted device.

 

Class 3 Medical Device – ISO 13485/FDA 21 CFR 820

Developed Business Systems Simulation for Design Assurance Testing of a patient management system, developed simulation services that allowed for testing of modules that could not be tested previously. These simulation services enabled test interaction with systems that were not practical to deploy in a test environment.


Class 3 Medical Device – ISO 13485/FDA 21 CFR 820

Contrast Injection system – Risk Assessment and Project consulting for software, program and hardware.

 

Class 3 Medical Device – ISO 13485/FDA 21 CFR 820

Developed custom verification environment and performed all verification activities for a WindowsCE embedded controller used for detection of impurities in food, performed all testing on User Interface, database, and sensor, and custom built power supply and motor controller.  Customer did not have any test automation before engagement with Blue Sages and achieved a 80% automation suite.

 

Commercial – Electronics Manufacturing Inspection Equipment ISO 9001:2000

Project Description: Creation and Verification of Manufacturing Test stations used to produce  embedded systems using non-contact component alignment of semiconductors with high speed pick and place machines.

 

Commercial – Electronics Manufacturing Inspection Equipment ISO 9001:2000

Project Description: Verification of PCB fiducial alignment sensors for pick and place machines.

 

Commercial – Electronics Manufacturing Inspection Equipment ISO 9001:2000

Project Description: Verification and Manufacturing Qualification of solder paste inspection systems used to monitor and control the finished quality of circuit boards. These systems allowed for in-process inspection of SMT circuit boards on the assembly line.

 

Commercial – Electronics Manufacturing Inspection Equipment ISO 9001:2000

Project Description: Supplier Development, Hardware “bring up” and hardware check-out. Project included creation of custom tools to allow for board “bring up” and hardware testing