Certification and Training for ISO 13485

Demonstrate your commitment to product quality and patient safety with ISO 13485 Certification from Eurofins E&E UK

Patient safety is paramount in the medical device industry, and product quality is non-negotiable. Eurofins E&E UK can support manufacturers meet these demands with certification to ISO 13485, the internationally recognised standard for quality management systems in the medical device industry.

Being able to demonstrate that your organisation is certified to ISO 13485 is the most effective way to demonstrate that you produce safe medical devices and gives you:

  • Access to expanded markets and opportunities
  • Evidence of conformity with regulatory requirements
  • A demonstrable commitment to quality and safety is often a pre-requisite for market access
  • Opportunities for cost savings, supply chain management and performance optimisation

ISO 13485 applies to all medical device manufacturers and industries that support medical device manufacture. This includes whole products and anyone supplying components used within complete medical devices. Suppose you are providing products that will become part of a medical device.

In that case, your customer will likely ask you to demonstrate that your products are safe and meet technical and regulatory requirements and that you can show that your processes are effective, managed and monitored to ensure consistent quality.

Demonstrating compliance with ISO 13485 can help you meet these demands and give you a competitive advantage.

In addition, many customers use ISO 13485 certification as a pre-requisite to supply, tender or deliver products. Not being able to demonstrate compliance with this global standard can prevent market access and restrict the ability to supply products.

Why use Eurofins E&E UK for your Medical Device Certification?

The Eurofins E&E UK medical device team can provide a complete QMS certification process.

We can offer a wide range of ISO 13485 services, including certification, training and gap analysis, all of which assist manufacturers in delivering compliant products to market as well as meeting regulatory requirements.

Alongside ISO 13485, we can offer certification to ISO 9001:2015, allowing you to develop an effective quality management system where ISO 13485 is not required.

For the EU market, we can also provide EU Notified Body services for MDD/MDR and IVD*1. In addition to certification for your medical devices, Eurofins E&E can also provide extensive testing and approval services for electrical and electronic products, allowing you to meet the regulatory demands of global markets.

To find out more about our ISO 13485 Certification services or to discuss any aspect of the certification of your Medical Devices, please use the form below, call us on 0330 430 3456 or use the live chat in the bottom right. We look forward to hearing from you.

Eurofins E&E UK consists of Eurofins York Ltd, Eurofins E&E ETC Ltd, Eurofins E&E Hursley Ltd, Eurofins E&E CML Ltd and Eurofins Electrical & Electronic UK London Ltd.

Note 1. Medical Device Directive (MDD) 93/42/EEC Notified Body services provided by Eurofins Product Testing Italy Srl (Italy); NB No. 0477, Eurofins Electric & Electronics Finland Oy; NB no. 0537 & Eurofins Product Service GmbH (Germany); NB No. 0681. Medical Device Regulation (MDR) 2017/745 Notified Body services provided by Eurofins Product Testing Italy Srl (Italy); NB No. 0477 and Eurofins Electric & Electronics Finland Oy; NB no. 0537