Concept Development

  • R&D and prototyping to support novel device concept generation and development (over 20 issued patents)

  • Landscape research and technical diligence to identify candidates for platform devices for combination products

  • Business case and NPV modeling to support product development decision making and early start-up fundraising

Product Development

  • Project and program leadership for device development efforts under 21 CFR 820, EU MDR, and UK/CA (Class II and III)

  • Definition and execution of all aspects of product development under Design Control

  • Identification and selection of external resources for product design/development through competitive bidding processes

  • Manage internal and external teams to perform product design, Design Verification testing, and the execution of Human Factors studies

  • Establish and perform Risk Management and documentation starting with product planning through post-market surveillance

  • Retrospective creation of a Design History File for an already developed product

  • CMC lead for projects in drug product process development

Regulatory Approval

  • CDRH pre-approval inspections for combination products

  • Notified Body audits in pursuit of MDSAP certification

  • Design History File remediation for successful FDA approval

  • Addressing 483 observations to maintain regulatory compliance

  • Assistance with the creation of a combination product QMS (procedures, policies, and training)

Commercial

  • Manage and maintain compliance with 21 CFR Part 4 requirements for commercial combination products

  • Life Cycle Management for commercial combination products to identify strategic plans for the evolution of the product

  • Identify and select CMOs for cGMP drug product and/or device manufacturing

  • Manage external vendors and CMOs for cGMP drug and device manufacturing