Services

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 | 1160 Vierling Drive #238, Shakopee MN 55379 | #952-233-1104 - info@canopymedical.com