Quality & Regulatory

Inspection Team profile

World-class instruments by experienced professionals

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.

ISO 13485 Certificate

MDR Certificate

Our quality capabilities

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. 

Partnering
Partnering

We partner with customers, openly sharing best practices and implementing world-class methods of  manufacturing and inspection.

Quality System
Quality System

Certified by BSI, our Quality Management System is robust and proven. We welcome customer audits at any time.

Validation
Validation

Fully validated special processes used throughout manufacturing provide consistent results and give you confidence.

Inspection
Inspection

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

Our regulatory capabilities

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.

Legal Manufacturer
Legal Manufacturer

With full regulatory ownership for thousands of products, you can trust us as the manufacturer of record for your products too.

Documentation
Documentation

We take care of all regulatory requirements, and openly share technical documentation to support product release.

Certified
Certified

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. 

Worldwide
Worldwide

Responsible for product release into USA, Europe, Australia, and NZ, and supporting worldwide deployment into other markets.

We work with great businesses

Looking for a company who can meet your quality and regulatory needs? 

Get in touch with us, we'd love to help solve your problems!