Quality & Credentials

All materials used conform to European and International Standards
These are our commitments to quality

Quality, credentials, and conformity

Quality is at the core of our manufacturing

Surgitrac® product quality assurance

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.

We hand finish and inspect each surgical instrument that we manufacture.

All of our instruments are batch and lot identifiable in line with the internationally recoginsed standard: EU Directive 93/42/EEC Quality Assurance: Medical Devices.

You can view our relevant credentials below

Declaration of conformity

Single-use class 1

We hereby declare that the below mentioned devices comply with European Medical Devices Directive 93/42/EEC.

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Declaration of conformity

Reusable Non-sterile Stainless Steel class 1

We hereby declare that the below mentioned devices comply with European Medical Devices Directive 93/42/EEC.

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Declaration of conformity

Reusable Titanium class 1

We hereby declare that the below mentioned devices comply with European Medical Devices Directive 93/42/EEC.

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Instructions for Use (IFU)

Single-use instruments

IFU document for Surgitrac Instruments single-use sterile ophthalmic.

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Instructions for Use (IFU)

Non-sterile instruments

IFU document for Surgitrac Instruments non-sterile reusable instruments.

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Reprocessing Guidelines

Reusable surgical instruments

Surgitrac Instruments - reprocessing guideline UK version.

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ISO

EN ISO 13485:2003 + AC:2009

Manufacture and disposal of disposable Ophthalmic instruments.

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Certificate Gamma Sterilisation

EN ISO 11137-1:2006

Sterilisation of healthcare products.

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Certificate Gamma Sterilisation

Q4N 16 06 71270 001

Gamma sterilisation of healthcare products.

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Certificate EO Sterilisation

Q4N 1604 59145 005

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

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Declaration

Ophthalmic custom made packs

Declaration of Latex and DEHP free product /manufacturing

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OP7 Document

document and data control / control of quality records

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