Your trusted partners for taking your medical device to market
Highly compliant and accelerated process to beat your competition to market
All our projects follow an iterative process that conforms to ISO 13485 and FDA. Although using this as a framework, we have developed our own lean and effective process, eliminating unnecessary steps and cumbersome processes.
Through years of experience, we have found the standard operating procedures of many larger companies to hinder innovation and limit speed. At AximoMD we strive to keep things simple, whilst retaining laser sharp focus on the project and customer milestones.
1. Briefing and planning
It starts with your patients, and their needs.
At this stage we support you to define:
The patient issue
Your technological solution
The market landscape
How to evaluate and classify the device
Every step from this stage is formally recorded, in a format conforming to ISO 13485
2. Concept design
Here’s where it gets exciting.
We take the patient-centred brief to inform:
A 3D CAD model
Low to medium detailed prototypes, helping us get rapid feedback on your medical device
Bench-top testing to evaluate real-world feasibility
Working closely with you through periodic design reviews, we iterate constantly to get the right solution.
3. Design and Development
Your medical device is starting to become a reality.
Thanks to the work we’ve done together in Stages 1 and 2, we can now:
Test the prototype for scale-up and manufacture
Perform critical tolerance stack-ups on the prototype
Review potential fail-models for the prototype
Develop manufacturing specifications for your medical device
At this point, there is one crucial stage left.
We have everything covered for your medical device including, moulding, automation, packing and labelling.
We work with a trusted network of manufacturers. We brief them for you based on the prototype testing, with a detailed manufacture transfer, including:
Bill of material
3D CAD data
The end result is a fully assured, prototype for your medical device.