Since our foundation in 1992, Enztec have remained at the forefront of compliance, with our in-house Quality and Regulatory teams tackling every challenge.
Is your team looking for help with new product development or contract manufacturing? Our Quality & Regulatory teams are experienced, helping customers ensure seamless product integration into their own systems.
Bringing a deep level of understanding and passion for orthopaedic instruments, Enztec is committed to exceeding customer expectations.
This extends from the way we make and control products through to the documentation we provide with every shipment. We work with customers to meet their documentation requirements, ensuring full transparency and confidence when accepting shipments.
We partner with customers, openly sharing best practices and implementing world-class methods of manufacturing and inspection.
Certified by BSI, our Quality Management System is robust and proven. We welcome customer audits at any time.
Fully validated special processes used throughout manufacturing provide consistent results and give you confidence.
In-process and finished goods inspection, combined with world-class quality controls, ensures your specifications are always met.
13485
ISO CERTIFIED
MDR
CERTIFIED
FDA
REGISTERED
TGA
REGISTERED
The regulatory requirements for orthopaedic devices are becoming increasingly complex and onerous. Remove this burden from your team by partnering with Enztec to seamlessly deliver your next MDR/CFR product.
We are proud of our reputation for world-class compliance systems. Our regulatory team are experienced at supporting worldwide release of products into Europe, USA, Australia, New Zealand, South America, Asia, Africa and the Middle East.
With full regulatory ownership for thousands of products, you can trust us as the manufacturer of record for your products too.
We take care of all regulatory requirements, and openly share technical documentation to support product release.
Enztec are ISO 13485 certified and deliver Class I, Ir, Im and IIa MDR products, as well as Class I and II CFR compliant products.
Responsible for product release into USA, Europe, Australia, and NZ, and supporting worldwide deployment into other markets.
