United Kingdom

Regulatory requirements and customer needs have driven Intersurgical to obtain certification of our Quality and Environmental Management Systems. We comply with the highest standards and regulations in order to legally design, manufacture, distribute and sell medical devices throughout the world and to give our customers confidence that our products are of the highest quality. 

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ISO 9001:2015 – Quality Management Systems

Certification to the internationally recognised Quality Management System ISO 9001:2015 enables Intersurgical to demonstrate commitment to quality and customer satisfaction. The framework of continuous improvement of company processes reinforces our corporate culture.

View the certificate

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ISO 13485:2016 – Medical Device Quality Management Systems

The basis of all regulatory requirements for placing medical devices worldwide markets is ISO 13485:2016. Regular audits by SGS help to monitor and improve our management systems.

View the certificate

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93/42/EEC – the Medical Devices Directive, The Medical Device Regulations 2002, 2017/745 – Medical Device Regulation

Access into European market and Great Britain markets is made possible by certification to the Medical Devices Directive 93/42/EEC, the Medical Device Regulations 2002 and the Medical Device Regulation (EU) 2017/745. This enables CE and UKCA marking of all Intersurgical products. The combination of certification to previously mentioned regulations and ISO 13485:2016 is accepted for market entry in many countries.

View the 93/42/EEC certificate

View the UKCA certificate

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ISO 14001:2015 – Environmental Management Systems

Customers are increasingly demanding environmentally responsible products and services. Intersurgical Ltd is certified to ISO 14001:2015, demonstrating commitment to minimising our environmental impacts. The system also provides a framework for managing the company’s environmental aspects, and complying with relevant legislation.

View the certificate

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MDSAP — Medical Device Single Audit Program

Certification to the MDSAP enables Intersurgical to satisfy the regulatory requirements of major medical device markets: Australia, Canada, Japan and the United States, by means of a single audit of Quality Management System.

View the certificate

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FDA 21 CFR 820 – Quality System Regulation, USA

All Intersurgical manufacturing sites are registered with the Food and Drug Administration (FDA), which enables Intersurgical products to be sold in the USA.

Intersurgical Quality Policy

We provide high quality products, which meet or exceed the mandated requirements from the differing global Medical Device Regulations and specific Standards, whilst fulfilling our customer requirements in respect of safety, effectiveness and performance.  Please view our Quality Policy.

View our Quality Policy

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Intersurgical Environmental Policy

We are committed to minimising the environmental impacts of the company’s products, activities and services and to continually review and reduce our carbon emissions, with an aim to achieve Net Zero by 2045.  Please see our full Environmental Policy.

View our Environmental Policy

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Renewable Energy Certificates

As part of our net zero mission, we are pleased to share that both our UK Head Office and our main manufacturing facility in Lithuania use 100% renewably sourced energy.  View our certificates below.

Renewable energy UK head office certificate

Renewable energy UAB Lithuanian manuafcturing site certificate

Product standards

Intersurgical products are designed to comply with applicable European and International product standards which ensures that performance requirements are met and that our products can be safely used with devices and equipment made by other manufacturers who work to the same standards.

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