Product Commercialisation

From NPI to a Fully Certified Product & Qualified Supply Chain

Certification & Regulatory Support

Development and Implementation of ISO13485
Provision of CE Technical File to MDR
Design & Development to 62304, 60601, 61010, and 80601 series
Risk Management and FMEA (14971)
User and Usability Studies
Clinical Study Support

Manufacturing & Automation

Design for Manufacture
New Product Introduction
Manufacturing Processes and Procedures to ISO13485
In-house and Outsourced Manufacturing Automation
Process Validation and Qualifications (IQ, OQ, PQ)

Supply Chain

Flexible Low Volume to High Volume Manufacturing
National and Global Suppliers
Consumables to Complex Electro-Mechanical Devices
Quality Technical Agreements
Supplier Qualifications