Medical Device & Product Commercialization

• Coordination of multiple disciplines in parallel
• Timeline & budget management
• Multi-phase approach to timeline & budget
• Coordinate with regulatory agencies
• Manage independent test labs for safety & compliance.

• Execute appropriate tooling strategy
• Top level & sub-assembly BOM's
• Schematic, gerber & assembly documentation
• Top & sub-level assembly drawings
• Coordination of product launch into production

• Product concept definition
• Electronic architecture design
• Mechanical concepts with electronic integration
• Proof of concept/prototyping
• 3D printing/proof of concept
• Hardware/firmware development
• Mechanical/electronic integration
• Development of complete build & test package

• Labeling, traceability
• Packaging development & implementation
• Warehousing, shipping/logistics support  

Regulatory Compliance Support Management

• Manage emissions testing (UL, CSA, CE)
• Manage safety testing (UL60601, FDA)
• Manage/trouble shoot compliance & product testing