How We Can Help You

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FDA Compliance Confidence 

  • NEW! Signet 62304 Complete Policy, Procedure, and Template Package: Implement a Software Quality System rapidly and to full compliance with both current US and European ISO 13485 regulations.
Software Validation  
  • Ensure your projects will meet the latest EN62304 FDA Software Validation Requirements to help ensure FDA approval with our Software Validation Review service. 
  • Prevent costly errors due first time inexperience developing medical devices by taking advantage of our combined experience of over seventy years designing products and managing projects in the medical device space with our Project Acceleration service.
  • Decrease the cost of implementing your company’s quality system for device development and validation by leveraging our extensive know-how and comprehensive documentation resources ready for your immediate implementation with our Quality System Direct service.  

Hands-On Engineering Expertise 

Proven senior technical experience that you can leverage in the highly technical medical product development space.

  • Software and Product Validation
  • Project Management 
  • Product Risk Management 
  • Regulatory Compliance 
  • Project Reviews  
  • Planning (Quality, Development, Verification & Validation) 
  • Requirements Development and Management 
  • Traceability Analysis
  • Software Development (Implementation) 
  • Electronics Design Development
  • V&V Test Design and Procedure Development
  • Specialized Testing Infrastructure

Cross-Discipline Program Management

  • Ensure cost and time saving coordination of all major stake-holders providing input to the program such Software Engineering, Mechanical Engineering, Electrical Engineering, Marketing, Sales, Product Training efforts with our Program Management Control service.

Investment Clarity

  • Avoid prospective costly investment mistakes due to technical or regulatory maturity of a potential acquisition or investment with our Investment Clear Sight assessment service.

Customized Instruction

On-site or off-site targeted training based on your present industry experience or areas of expertise.

  • Cost Saving Compliant Medical Device Software Development Process
  • Efficient Medical Device Software Verification and Validation
  • Cost-Effective Validation of Production and Quality System Software
  • Effective GUI Requirement Development

Targeted Consulting

What issues are you currently dealing with? We can help you…

  • Are you working with your first medical device development project and want help in identifying what potential barriers might block your success? 
  • Are you attempting to develop or struggling to work with a Quality Process for device development and validation and need assistance putting effective Standard Operating Procedures in place?
  • Do you have development, production, or quality barriers due to employees that are not from the regulated medical device industry who are having difficulty adapting to the regulated environment?
  • Did you struggling with regulatory compliance problems in engineering and software in the past and now want ongoing help to avoid future problems?




Access the FREE  Report:

List of Essential Documents and Templates You Need for IEC EN62304 Compliancy

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