Regulatory Testing Services
Lucideon offers a comprehensive range of regulatory testing services applicable to a range of industries to ensure your products and materials meet the required safety and performance standards before reaching the market. Our regulatory testing is performed under strict accreditation to ensure precision, reliability, and acceptance of your results.
Why Regulatory Testing Matters
Regulatory compliance is mandatory for many products across different industries such as medical devices, consumer goods, nuclear materials, and construction products. Working with Lucideon gives you access to:
- Accredited testing: our testing services are accredited by the United Kingdom Accreditation Service (UKAS) ensuring that all processes meet the highest quality control standards
- Expert guidance: our experts help you navigate complex global regulations, ensuring your products meet all necessary guidelines including ISO, ASTM, and FDA standards
- Comprehensive support: from submission to market approval, our experts provide detailed analysis and reports to help you achieve regulatory compliance swiftly and efficiently
Our Regulatory Testing Services
Lucideon offers regulatory testing for a variety of products across multiple sectors. Please follow the relevant link below for more information on our services:
- Orthopaedic Implants – 510(k) Submissions
We perform biomechanical, wear, and fatigue testing to meet stringent FDA requirements for orthopaedic implants, ensuring they are safe and effective. - Orthopaedic Regulatory Strategy Testing
Our regulatory strategy expertise can support you from product development to submission, helping you navigate the complex requirements for orthopaedic devices. - Medical Devices – Regulatory Submission Support & Testing
Lucideon’s experts support your medical device development from concept to approval, offering a range of testing services, including biocompatibility testing, safety evaluation, and performance validation. - Consumer Products – Efficacy Testing
We validate the efficacy of your consumer products to ensure they meet regulatory standards for safety and performance. Our services include antimicrobial efficacy, stability validation, and toxicology assessments for cleaning and cosmetic products to OTC medicine and more.
- CE Marking of Products
Our team helps you achieve CE marking compliance for products sold in the European Economic Area (EEA), performing all necessary tests to meet regulatory guidelines. - Slip Resistance Testing
We provide slip resistance testing for floor coverings, tiles, and other surfaces to ensure they meet safety regulations and performance standards. - Tableware, Tiles, and Sanitaryware – Performance Testing
Lucideon's testing ensures your products meet key performance standards, including durability, resistance to wear, and safety compliance. - Nuclear – Commercial Grade Dedication Testing
We offer commercial grade dedication testing for nuclear materials to ensure compliance with regulatory standards and safe use in critical environments. - Nuclear – Stress Corrosion Cracking
Our experts conduct stress corrosion cracking tests on nuclear materials to verify their long-term durability and safety under critical operating conditions.
Why Choose Lucideon?
Lucideon stands out in the regulatory testing industry because of our experience, expert teams, and state-of-the-art testing facilities. We are trusted by global leaders across a range of industries to deliver accurate and compliant testing results.
- Accredited by UKAS: all testing services are performed under UKAS accreditation, guaranteeing high standards of precision, accuracy, and global recognition.
- Experience Across Industries: we have decades of experience providing regulatory testing to industries including healthcare, consumer products, nuclear, and construction materials.
- Tailored Testing Solutions: our experts work closely with you to develop customized testing programs that fit your specific regulatory needs.
- Novel Method Development: our team of experts develop novel testing methods for innovative products and materials to meet compliance standards in cases where no established testing methods exist.
Contact us today to discuss your regulatory testing needs or explore our other services, including materials testing, failure analysis, and consultancy.
For more detailed information, visit our UKAS schedule of tests and certificates here
White Papers
In this white paper we look at the case for using one supplier for regulatory approval testing, using the example of hydroxyapatite testing
This white paper explores the market drivers for abuse deterrence and identifies possible solutions
This paper will explore the applications of Digital Image Correlation technology in the healthcare sector
This white paper offers additional guidance that could help support implant manufacturers in their decision-making and justifications for regulatory submissions
The goal of this white paper is to demonstrate the risk of working with the wrong material, to highlight the upside when the right material is selected
This process involves ensuring cleaning procedures used to clean medical devices and instruments are effective at removing contaminants and microbes
Case Studies
Lucideon has worked with Greatbatch Medical to help them gain FDA approval
Environmental monitoring qualification of new facilities
Lucideon uses surface analysis to investigate hair care products