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Quality & Credentials

Quality, credentials, and conformity

Compliant with MDR, EU and International Standards

These are our commitments to quality

Surgitrac® product quality assurance

Surgitrac Instruments product quality is at the core of our manufacturing processes.

We have robust systems in place to ensure the consistent quality of our surgical instruments.

Products are subject to a rigorous quality checking process, from development through to the final production.

Our CE-marked single-use and reusable surgical instruments are subject to several inspections, during the manufacturing process.

All of our instruments are batch and lot identifiable in line with the internationally recognised standards.

Device-specific IFU is available on request.

You can view our relevant credentials below.



Declaration of Conformity 2021

Class 11a

Declaration of Conformity 2021

Download

Declaration of Conformity 2021

Non-sterile single use

Declaration of Conformity 2021

Download

EC Representative Cert

Advena

EC Representative Cert

Download

ISO Surgitrac Instruments UK

EN ISO 13485:2016 and 13485:2016

ISO Surgitrac Instruments UK

Download

ISO Certification

Surgitrac Sihong

ISO Certification

Download

EC Certification

Surgitrac Sihong

EC Certification

Awarding body TUV

Download

Instructions for Use (IFU)

Single-use instruments

Instructions for Use (IFU)

IFU document for Surgitrac Instruments single-use sterile ophthalmic.

Download

Instructions for Use (IFU)

Non-sterile instruments

Instructions for Use (IFU)

IFU document for Surgitrac Instruments non-sterile reusable instruments.

Download

Reprocessing Guidelines

Reusable surgical instruments

Reprocessing Guidelines

Surgitrac Instruments - reprocessing guideline UK version.

Download

Quality Policy Statement

BS EN ISO 13485:2016

Quality Policy Statement

Download

Labour Standards Assurance System

2020

Labour Standards Assurance System

Download

Certificate Gamma Sterilisation

EN ISO 11137-1:2006

Certificate Gamma Sterilisation

Sterilisation of healthcare products.

Download

Certificate Gamma Sterilisation

Q4N 16 06 71270 001

Certificate Gamma Sterilisation

Gamma sterilisation of healthcare products.

Download

Certificate EO Sterilisation

Q4N 1604 59145 005

Certificate EO Sterilisation

Ethylene Oxide (EO) Sterilisation certificate single-use medical devices

Download

TUV Certification

GA Health Company

TUV Certification

Download

TUV Certification

Ophthalmic procedure packs

TUV Certification

Download

TUV Certification

Class I medical devices

TUV Certification

Download

Declaration of Conformity

Latex free ophthalmic custom made packs

Declaration of Conformity

Declaration of Latex and DEHP free product /manufacturing

Download

TUV Certification

Class IIa IIb III medical devices

TUV Certification

Download

Instructions For Use (IFU)

Ophtec Netherlands

Instructions For Use (IFU)

Download

Instructions For Use (IFU)

Ophtec Netherlands

Instructions For Use (IFU)

Download


Surgitrac product quality

Surgitrac® Instruments product quality is at the core of our manufacturing processes

We have robust systems in place to ensure a consistent quality of our surgical instruments.

Products are subject to a rigorous quality checking process, from development through to the final production.

Our CE marked single-use and reusable surgical instruments are subject to several inspections, during the manufacturing process.

All of our instruments are batch and lot identifiable in line with the internationally recognised standard

Device specific IFU’s available on request.

You can view our relevant credentials below.