Baymar Solutions

Technical guidance through every stage of the development cycle, utilizing structured phase-gate approaches that align with FDA guidance for design controls.

• Mechanical Design & Drafting

  Creating innovative and robust 3D CAD parts and subsystems using tools like SolidWorks and Pro/Engineer.

• Systems Engineering

  Aligning all elements of a system design to verify that they function in harmony at the system level.

• Geometric Dimensioning & Tolerancing

  Applying ASME Y14.5 standards to ensure precise technical tolerances and manufacturability.

• Specialized Design Arenas

  Developing complex designs including robotic motion, fluidic systems, and tooled components.

Specialized scientific assistance for companion diagnostics and in-vitro diagnostics development.

• Assay Development

  Supporting electro-mechanical and assay chemistry development for IVD systems.

• Technical Literature & SOPs

  Creating scientific literature reviews, quality control guidelines, and standard operating procedures.

• Regulatory Strategy & Submission

  Formulating launch strategies and drafting documentation necessary for FDA submissions.

Flexible technical capacity on demand, supplementing existing teams either temporarily or long-term.

Program schedule and cost oversight utilizing structured frameworks to meet aggressive commercialization milestones.

• Agile & Scrum Methodologies

  Facilitating rapid adaptation to changes and emphasizing stakeholder communication.

• Vendor Collaboration

  Managing supplier interactions, configuration control, and schedule maintenance.