CERTIFICATIONS & REGULATORY COMPLIANCE
Registered with the U.S. Food and Drug Administration as a medical device establishment, enabling compliant access to the world's largest healthcare market.
Certified to ISO 13485:2016 - the internationally recognised quality management standard for medical device design, development, and manufacturing.
Fully aligned with EU Medical Device Regulations (EU 2017/745), ensuring compliance with the latest European market access requirements for medical devices.
25+ Years Experience
Medical Device Manufacturing
International Production Expertise
Scalable Clinical Solutions
Product Strategies
Product Development
Product Industrialisation
Contract Manufacturing
Quality Governance
Global Procurement
Product Assessment
Failure Resolution
Lifecycle Optimisation
Operational Transformation
Single Platform, Full Control
Precision Engineering
Regulatory Confidence
Predictable Outcomes
Peter Tomlinson
Rohan Monico
Michal Hajdon
Allan Taylor
John Wiltshire
Chris Buss
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