Who we are

Digital innovation conceived, developed, and backed by industry experts.

270 laboratories globally

With over 9,000 Engaged Experts in over 270 facilities in the Americas, Europe, Middle East, Africa, Asia and Australia, we are the 'go to team' for all of your testing, inspection, certification and calibration needs.

55,000 customers worldwide

We support thousands of customers in a diverse range of market-leading scientific, technical, and engineering industries where product innovation and quality are of paramount importance, and where failure in use is not an option.

Nearly 200 years of history

We can trace our origins back to 1827. Element businesses have been involved in materials and product testing that gave the world the Model T Ford, put Concorde into the skies and has helped keep Venice afloat.

Meet some of our experts

Our medical regulatory experts oversee every customer’s case.

Nicole Small

Nicole is our Senior Manager of the Medical Technology Team. She is an experienced regulatory professional with extensive experience in the testing and regulation of medical devices. Her career spans over 30 years, which includes  leading on significant public safety issues, educational and operational programs for the MHRA (UK's regulator; Medicines and Healthcare products Regulatory Agency).

James Pink

James is our Senior Director of global medical technology testing, inspection and certification. He is an accomplished technical expert with a 25-year career in medical technology product safety and market access and has audited hundreds of medical device companies as part of the European CE marking requirements.

Robert Burek

Robert has over 30 years experience in product safety and regulatory compliance, primarily focusing on medical devices and IT equipment. Robert is an IECEE CB Scheme Lead Assessor and a technical expert in this area. He has also been involved in standards development work for major organizations like IEC, UL, CSA, NIJ, and the FDA ASCA program.

Michael Kipping

Michael is our Director of Medical Technologies in EMEAA. He has over 17-years of experience, working at companies like Boston Scientific & BIOTRONIK; and has spent ~7-years helping start-ups launch safe medical devices as part of MHRA and Innovate UK.

Meet some of our data scientists:

Abhishek Shivkumar

Abhishek brings over 15 years of expertise in Artificial Intelligence and Machine Learning. His extensive experience in Natural Language Processing (NLP) and Text Analytics enabled him to successfully design and implement comprehensive data science solutions for practical, real-world applications in different verticals including medical, fashion, and advertisement. Abhishek is a contributor to the AI field, with multiple publications and over 10 granted patents.

Natalia Viani

Natalia is a results-driven Data Scientist with a strong background in AI, Machine Learning, and Natural Language Processing (NLP). She holds a PhD in Bioengineering and Bioinformatics and specialises in applying advanced information extraction and summarisation techniques to derive valuable insights from diverse domains, including clinical and legal texts.

Raquel Vaz

Raquel is our Principal Data Scientist with over 6 years of experience developing AI-powered products in both B2B and consumer spaces. She holds a PhD in Applied Mathematics from Imperial College London and specialises in applying Natural Language Processing (NLP) for recommendation engines, content extraction and categorisation.

Reimagining the compliance and regulatory process

We understand the urgency of bringing life-changing tools to patients. That's why we’re combining our expertise with investment in cutting edge AI technology to reimagine how we best support our customers and bring safer products to market sooner.

A long history in medical device regulation

As a comprehensive medical device testing partner, you’ll enjoy the benefit from our holistic understanding of the end-to-end process. From feasibility and R&D to product development and production quality control. Not only are we able to map your regulatory pathway but we offer a full suite of medical device testing to get your product to market.

1,000+ accreditations and approvals

We are one of the most accredited organizations in the TIC sector. These are an independent endorsement of the quality of service we deliver, which enables us to make certain that the materials and products we test are safe, compliant and fit for purpose.

View RegNav Resources

See all of our industry-expert-authored whitepapers to aid you through your regulatory journey.

Start your journey

Whatever stage you’re at, RegNav can support

We support medical devices across all risk classifications

We support all pathways

We support the US, UK/EU and other jurisdictions that use IMDRF