Surtex Instruments Limited
Surtex Instruments is a medical instruments manufacturer from United Kingdom. Our commitment to innovative solutions, excellence and quality craftsmanship in the manufacture surgical instruments has made us one of the most trusted brands by healthcare professionals. Surtex Instruments is a privately owned medical technology company dedicated to innovation and excellence in the craft of surgical instruments. The company started as a specialist instruments supplier to UK hospitals and gradually expanded to deliver globally. At Surtex each instrument is meticulously handcrafted by the most qualified instruments artisans who exceed standards set out in CE, FDA and ISO 13485 requirements. Our commitment to providing a one-stop instruments solution ensures you can rely on us for a broad range of surgical specialities such a cardiovascular, orthopaedic, neuro, micro, ent, ophthalmic and more.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
About Us
Surgeons are highly talented and skilled individuals. They operate under significant time constraints and are required to make split-second decisions while performing complex operations. At Surtex we understand that in such a scenario the surgeon requires tools that are not just fit for the purpose but are reliable, dependable and crafted by a company that has a track record for a relentless pursuit for excellence in the making of surgical instruments.
Our commitment to quality is more than a stamp; it’s embedded in our process! Each and every instrument is the result of working knowledge of surgeon’s art, exact knowledge of instrument specifications and industry’s leading quality assurance programmes.
All our instruments carry a limited lifetime warranty and are custom blended from a high carbon and chromium steel alloy conforming to BSEN ISO 7153-1 or BS 5194-1 (where applicable). We are ISO 13485 /ISO 9001 (SGS UK) certified and CE approved to ensure compliance with the standards defined in line with medical devices directive 93/42/EEC.
Lifetime warranty – when you need itWe encourage our customers to calculate lifetime costs prior to making purchase decisions and investing in surgical instruments.
“Surtex Instruments are guaranteed for life against manufacturing defects of material and workmanship. This guarantee is void if instruments are not maintained properly, or if they are not used for their intended surgical purpose. (conditions apply*).”
Tungsten carbide inserts on scissors, needle holders and wire cutters are guaranteed for three years. Replacement parts, such as springs, are guaranteed for one year.Surtex Instruments will repair or replace, free of charge, any surgical instruments that does not meet its functional requirements when used for its intended purpose and maintained properly.
Surgical instruments represent a significant proportion of hospitals total assets. Hospital and health centres are often required to minimize costs of surgical instruments without impacting quality or patient health. Decision-makers tend to respond via group purchasing contracts & multiple quotes to shop around for the lowest price. However, this approach has significant drawbacks as numerous instrument companies have focused on competing on price alone with a disregard towards instrument quality while claiming their instruments to be guaranteed and free of defects. The outcome for the buyer being, a perceived notion of a quality instrument, which is actually little more than a knock-off and delivers only poor value for money.
At Surtex® Instruments, our success has been based on helping customers navigate successfully through the instrument procurement process by identifying real value for money through fair comparison. We believe that quality should be affordable and you should not pay too much for overpriced brands and neither should you pay too much for a substandard instrument.
Our instruments present a viable alternative to overpriced brands while building on our hard-earned reputation for delivering the highest quality products and value for money all in one package.
Quality Management System
Quality Manufacturing is A System, Not Just A Slogan.
In the European Union Medical Devices are subject to a series of uniform laws and the EC directive places rigid demands on surgical instruments. Surtex Instruments is proud to claim that we have always surpassed the legal requirements to ensure that each instrument reaching the surgeon’s hand is always a testament to surgical craftsmanship.
BS EN ISO 9001:2015
Surtex Instruments Ltd has implemented a quality management system, which has been certified to ISO 9001:2015. This certification ensures that the company constantly delivers products that meet all customers’ needs and regulatory requirements and requires that we commit to the improvement of the system and ongoing conformity to regulations.
The system has been audited by SGS UK, which is a UKAS accredited assessor and is subject to successful surveillance audits to ensure ongoing compliance.
BS EN ISO 13485:2016
We are proud to have achieved recognition as a company certified to the ISO 13485 medical device manufacturing standard.
The key aspects that the ISO 13485 requirements are as follows:
Promotion and awareness of regulatory requirements as a management responsibility.
Controls in the work environment to ensure product safety.
Focus on risk management activities and design control activities during product development.
Specific requirements for inspection and traceability for medical devices.
Specific requirements for documentation and validation of processes for medical devices.
Specific requirements for verification of the effectiveness of corrective and preventive actions.
EC Declaration of Conformity
This deceleration assures that products supplied by Surtex Instruments are in conformity with the essential requirements of the European Medical Devices Directive (93/42/EEC) and are manufactured to the highest standards of craftsmanship following the relevant national and international standards.
We continue to work towards compliance with the new MDR (2017/745). The new regulation will come into force in May 25th 2024.
FDA (U.S. Food & Drug Administration)
We are registered with the FDA (U.S. Food & Drug Administration). The Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy, and security of medical devices in the USA. Our US Agent and Official Correspondent with FDA is Business Support International.