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.