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Services


Canopy Medical is a consulting firm that provides strategic product development services including regulatory, clinical, quality, product development, business development and operations throughout the product life cycle.
Research, Concept & Feasibility
  • Concept Development
  • Feasibility Evaluation
  • Market Assessment
  • Quality System Development
  • Regulatory & Clinical Strategies
  • Clinical Literature Reviews
  • Technical and Regulatory Due Diligence
  • IP Review and Evaluations
Planning
  • Strategic Project Planning
  • Business Development
  • Project Management
  • Risk management
  • Clinical Plan
  • Master Validation Plan
  • Regulatory Plan
  • FDA Liaison
Design and Development
  • Design requirements
  • Hazard and Risk Analysis
  • Engineering prototypes
  • Design history files
  • Manufacturing Plans
  • QSR, GMP & MDD Quality Systems
  • Pre-submission Meetings
Verification and Validation
  • Protocol and Report Writing
  • Safety Validations
  • Functional and Performance Studies
  • Usability Studies
  • Clinical Study Development
  • Coordination of Testing Resources
  • Documentation and Coordination of Process Qualification
  • Supplier Audits
  • IDE, IND Preparation
Transfer and Commercialization
  • Design Transfer Plans
  • Regulatory Submissions (Global)
  • Post Market Surveillance
  • Risk Benefit Analysis
  • Internal Compliance Audits
  • QSR, GMP, IS0 13485 Compliant Quality Systems
 
 
    Canopy Medical LLC | 1160 Vierling Drive #238, Shakopee MN 55379 | #952-233-1104 - info@canopymedical.com