Medical Device Directive Safety Testing
Element provides medical device directive testing for products ranging from bandages to wheelchairs.
Locations
Malvern
Electrical Equipment (Safety) Regulations 2016
Element provides the guidance and services you need to meet the requirements of the Electrical Equipment (Safety) Regulations 2016.
Product Compliance Testing Services
Element provides a full suite of product compliance testing services, including CE marking, zigbee certification, EMC testing, and more.
IEC/EN 61010-1: Electrical Laboratory Equipment Testing
Element provides testing and certification to IEC/EN 61010-1 to assess the safety and essential performance of electrical laboratory equipment.
Experts
Understanding the requirements to gain Global Market Access (GMA)
IEC 60601 Medical Device Safety Testing
Element provides testing and certification to IEC 60601 to assess the safety and essential performance of electrical medical devices.
What is the RCM Mark? Frequently Asked Questions
Medical Device Regulation (MDR) Annex XVI - How Can You Prepare?
What is the new EU Medical Device Regulation (MDR) Annex xvi and how can you prepare? Read our online guide to learn about the changes within the regulation and how you can prepare.
What is an EMC Risk Assessment?
The European EMC Directive (2014/30/EU) was updated in 2014, replacing the old directive (2008/108/EC) becoming mandatory from April 2016 for new products entering the EU.
News
Element to Host Industry-Leading Testing and Compliance Seminar in the UK
Wireless Devices A Guide to Compliance in the US and EU
Our experts provide a comprehensive guide to wireless device compliance in the US and European markets.