Design & Development
OUR PROCESS
Design Concept
Phase 0
Our Process
We are your reliable partner, orchestrating every aspect of your project ensuring your product aligns with full compliance and regulatory standards. Explore our project phases
Brainstorming
Research
Proof of Concept
Prototype Evaluation
Product Specification Initiation
Input
Phase 1
Design Input Requirements
Design Specifications
Patent Review
Regulatory / Clinical Planning
Risk Management Planning
Output
Phase 2
Product / Packaging Design
Verification / Validation Planning
Design Risk Analysis (DFMEA)
Purchase Planning
Regulatory Preparation
Verification & Validation
Phase 3
Verification / Validation Reports
Manufacturing / Quality Processes
Process Risk Analysis (PFMEA)
Clinical Studies / Reports
Process Validation Planning
Device Master Record
Transfer & Release
Phase 4
Process Validation
Risk Management Reports
Regulatory Submissions / Clearances
Design Transfer
Equipment and Capabilities
Prevailing Medical has a large range of equipment, including 16 carrier steeger braider RDN extruder and puller, 3D printing, 10 up reflow machine, batch oven, laser, welding, hot jaw bonding, UV bonding, nitinol forming, and more. Discover our capabilities or get in touch to initiate your project today.
Meet Our Team of Experts
At Prevailing Medical we are your trusted experts bringing in over 100 years of experience within the medical device market.