Research & Development

Canopy Medical offers Research & Development services to companies involved in medical product development. These services include, but are not limited to:

Strategy Development

• Regulatory strategy
• Due diligence – Technical and regulatory
• Integrated planning to achieve technical, scientific and regulatory goals

Project Management

• Project coordination
• Gap Analysis
• Project Planning – Gantt Charts
• Manage to Schedule – Deadlines
• Project Meetings & Design Reviews
• Strategic Planning

Intellectual Property

• IP Review and Evaluation
• Patent Specification Writing

Concept Development

• Product Concept Evaluation per Regulated Industry Requirements
• Refinement of Product Concept
• Feasibility Studies
• Competitive & Market Analysis
• Literature Reviews – Technical and clinical

Design & Development (R&D)

• Master Validation Plans
• Design Validation Studies
• Product Specification Development
• Rapid Prototype Models
• Instructions For Use (IFU), Service Manuals and Users Manuals
• Part & Assembly Drawings
• Test & Production Equipment Design
• Process Validation Studies (product, sterilization, package integrity, shelf life and stability testing, etc.)
• Design Control System Implementation & Training
• Design History File (DHF)

Risk Management

• Risk Management per EN ISO14971, EN 12442
• Risk Analysis per FMEA / FMECA / HAZOP / FTA
• Technical failure investigations

Testing

• Preclinical Bench Testing
• Animal Studies
• Human Cadaver Studies
• Packaging Performance and Shelf-life
• Process Validations
• Design & System Performance Verifications
• Reliability Testing
• Product Validations
• EMI/EMC
• MRI Compatibility
• Production & Test Equipment Qualifications (IQ/OQ/PQ)

Technical Writing

• SBIR Grant Request Writing
• Peer reviewed literature
• Scientific publications