Ensuring that Your Project is Managed or Supported from Concept to Completion

Strategic guidance and hands-on support to help you achieve your goals efficiently and effectively.

Encompassing every stage of the product lifecycle

Where Innovation Meets Excellence

Lincé Consulting offers project management solutions and broad cross-functional technical support spanning R&D, manufacturing, quality and regulatory. We are dedicated to quality and client satisfaction and offer a comprehensive range of services tailored to meet the unique needs of every project. We understand the critical importance of ensuring the design and development process to support your clinical, regulatory and marketing goals. Our team brings decades of combined experience to the table, ensuring that your project is managed or supported from concept to completion.

Our project management and engineering services encompass every stage of the product lifecycle. Whether you are in the initial stages of ideation, navigating regulatory hurdles, or planning for manufacturing process validation, we provide strategic guidance and hands-on support to help you achieve your goals efficiently and effectively.

Our services cover a wide range of project scopes and industries, particularly in the medical device sector, and offer expertise in project management, engineering, quality assurance, regulatory compliance and technical documentation.

Project Engineering Services

  • Project Management Services
    • Development of project plans and establishing road maps and milestones to meet product development goals
    • Planning and leading teams through project development cycles from ideation to market
    • Conducting technical and design reviews ensuring compliance with design control requirements
  • Technical Consulting Services
    • Providing technical expertise and guidance to project teams for specification development, test methods, and regulatory requirements
    • Conducting engineering reviews to ensure compliance with regulatory standards and to ensure technical documentation meets a high degree of technical rigor
    • Technical writing to support regulatory submissions, procedures, presentations, and user manuals
  • Quality Engineering Services
    • Conducting gap analyses of technical and design documentation and recommending solutions to ensure quality compliances
    • Leading risk management processes and assessing technical design, clinical, and user risks
    • Statistical data analysis to support engineering claims
  • Pre-Clinical Study Services
    • Technical protocol and report development of pre-clinical studies
    • Planning, managing, and execution of pre-clinical studies with external test laboratories
    • Conducting technical reviews of pre-clinical study data to identify gaps and improvements
  • Manufacturing Support Services
    • Developing process specifications and tooling to support new production line start-up
    • Developing, improving, and characterizing manufacturing processes and environments
    • Developing Master Validation Plans including process and test method validation
    • Developing test methods, protocols and reports, and executing validation testing
  • Product Development Services
    • Prototyping design iterations or tooling to support product development
    • Developing Verification and Validation Plans, protocols and reports
    • Conducting verification and validation testing or collaborating with contract manufacturers, design houses, and test labs
Our Services
  • Regulatory
  • Clinical
  • Quality
  • Project Engineering

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