RAPID DHF DEVELOPMENT & REMEDIATION
Your design is only as good as your Design History File
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CONCEPT DEVELOPMENT
Ideation
Proof of Concept & Technology
Market Assessment
PLANNING AND ARCHITECTURE
System / Product Requirements
Regulatory Strategy
Risk Management Plan
Human Factors Plan
Hazard Analysis
Design Validation Test Plan
Project plan
Implant & Instrument Design (Specs, Models, Drawings)
Engineering Build and Documentation
Implant Performance Analysis (FEA)
Design Analysis Testing
DFMEA Report
Manufacturing Work Instructions and Routers
Packaging Design (Specs, Models, Drawings)
Labeling Design (Specs, Models, Drawings)
V & V Test protocols, eg:
Sterilization
Biocompatibility
Cleaning
AA/RT/Distribution
BOM & Approved Vendors
DETAILED DESIGN AND DEVELOPMENT
Labeling & Patient Inserts
Instructions for Use (Surgical Technique Guide)
Device Master Record
Verification & Validation Builds & Documentation
Manufacturing Process Qualification Report
Verification Test Reports
Test and Optimization
Validation and Launch
System Validation (clinical studies, cadaver labs, etc)
Risk Management File
Trace Matrix
Regulatory Submission (clinical study or approval/clearance e.g. 510(k))