StarFish Medical

StarFish Medical helps teams develop medical devices through product definition, engineering, regulatory work, prototyping, and manufacturing. Its services also cover quality systems, human factors, software-enabled devices, testing, and ongoing compliance support.

Device Design and Development

• Define and engineer medical devices from concept through market-ready product development. Pathfinder, its proprietary product-definition and engineering process, supports precise device definition.
• Move device concepts through rapid prototyping, testing, risk management, and design-for-manufacturing activities during development iterations.
• Develop combination products, including drug delivery devices designed for targeted delivery and at-home use.
• Build connected and software-enabled devices by integrating mechanical, electrical, firmware, software, and optical systems; diagnostic programs can also address data capture, processing, and delivery.

Regulatory and Quality Operations

• Plan medical device and IVD regulatory strategies across FDA, EU MDR/IVDR, Health Canada, and other global pathways, including FDA Q-Submissions and Pre-Submissions.
• Prepare submission content and support document preparation, regulator interactions, and response management across the submission lifecycle.
• Assess regulatory gaps and transition needs to strengthen documentation, risk management, and quality systems for changing requirements. ELLA, an AI-powered regulatory compliance tool, filters and ranks FDA guidance for a specific use case.
• Design and implement quality management systems tailored to a client’s business model and global compliance needs, including QMSR, ISO 13485, MDSAP, and MDR/IVDR frameworks.

Manufacturing, Assembly, and Testing

• Establish medical device manufacturing processes, suppliers, documentation, quality controls, testing, and production planning for contract manufacturing programs.
• Assemble clinical-grade devices in cleanroom or controlled environments, with prototype and volume production in ISO 13485-certified facilities equipped with Class 10,000 cleanroom capabilities.
• Support design controls, traceability, manufacturing documentation, and design history file activities during development and clinical manufacturing.
• Provide rapid prototyping, verification and validation testing, and manufacturing through ISO-certified laboratories and cleanroom environments.

Human Factors and Ongoing Quality

• Apply human factors engineering and usability testing to support user-centered device design and compliance with FDA and international standards.
• Provide post-market QA/RA leadership, including change control and audit readiness, and strengthen verification, validation, and risk management practices as products evolve.
• Evaluate supplier capability, component availability, qualification requirements, and production risk against the product intended for manufacture.

Best Fit

• Medical device and IVD companies seeking support for product design, engineering, regulatory affairs, prototyping, testing, or contract manufacturing.
• Teams needing coordinated support across device development, cleanroom assembly, quality systems, regulatory submissions, and post-market changes.