Eurofins Electrical & Electronics offers a range of testing and certification services to help you get your medical devices to market on time and within budget. Our international network of accredited electrical and electronics laboratories and certification bodies offer a comprehensive range of testing and certification services for active and non-active medical devices and In-Vitro Diagnostic Medical Devices (IVDs).

Our experience and expertise give you the confidence to design, develop and deliver tested and certified products to your chosen markets efficiently and cost-effectively.

Our core services include:

• Medical Device Certification
  
  • Notified Body Services for the EU
  • Approved Body Services for the UK
  • North American Certification Services
• Quality Management Systems & Audits
• Testing of Medical Devices
  
  • Product Safety
  • EMC
  • Radio/Wireless
  • Mechanical & Climatic Simulations
  • Performance
  • Cybersecurity

Meet the demands of global markets

The market for medical devices is global, and in all important markets, regulatory requirements are in place to ensure that products meet the highest standards and do not present a risk to patients or users alike.

These regulatory requirements and approval methods differ between countries and only in a few cases are these mutually recognised.

For example, products must comply with EU Regulations in the European Economic Area, the requirements of the MHRA in the UK, the FDA’s requirements in the United States, Health Canada’s requirements in Canada, JPAL regulations in Japan and TGA requirements in Australia.

In addition to these markets, many important countries globally have their own regulatory systems for medical devices and managing these requirements is complex and time-consuming. We provide a single point of contact for the testing and certification of your medical devices, allowing you to access your chosen markets quickly, easily and cost-effectively.

We offer a range of Quality Management System Certification services for manufacturers of Medical Devices.

ISO 13485 Quality Management System (QMS)

The global standard ISO 13485 stipulates the quality management requirements for regulatory
purposes for all actors involved in the life cycle of medical devices (manufacturers, suppliers,
distributors, etc.) and is the certified quality management system that is most broadly recognised in the medical sector.
We have four ISO 13485 QMS Certification Bodies to assist in your compliance process:

• Finland - Eurofins Expert Services, No. S021
• Germany - Eurofins Product Service GmbH, D-ZM-12092-01-00
• Italy - Eurofins Product Testing Italy s.r.l., No. 133A
• UK - Eurofins E&E CML Ltd UKAS No. 8175

Medical Device Single Audit Program (MDSAP)

Our certification body in Finland acts in cooperation with an MDSAP-recognised auditing organization, DQS Medizinprodukte GmbH, and can provide your organisation with MDSAP certification.
Please note that this service is only available in conjunction with the Notified Body services provided by Eurofins Expert Services in Finland (NB No. 0537).

ISO 9001 Quality Management System (QMS)

In addition to the ISO 13485 services, we can also offer certification to ISO 9001:2015.
Although ISO 13485 Certification is a real asset for most areas of Medical Device manufacturing, for companies with additional products or services that fall outside the scope of ISO 13485, a QMS certified to ISO 9001:2015 demonstrates a commitment to product quality.