Regulatory Testing Services
Lucideon has a wide scope of regulatory testing in its portfolio of services. Regulatory testing is performed to ensure the safety and performance of products before they go on sale, and it is mandatory for certain products. The mandatory nature of the testing means that all tests follow recognised standards and are usually performed under our accreditation schedule (UKAS in most cases).
Lucideon currently performs regulatory testing for the following products, please follow the relevant link for further information:
- Orthopaedic implants 510k
- Orthopaedic regulatory strategy testing
- Medical devices - regulatory submission support & testing
- Consumer products – efficacy testing
- CE marking of products
- Slip resistance testing
- Tableware, tiles and sanitaryware – performance testing
- Nuclear – commercial grade dedication testing
- Nuclear – stress corrosion cracking
Our UKAS (United Kingdom Accreditation Service) schedule and of tests and certificates can be found 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
Nosocomial infections (hospital acquired infections) are a major but often preventable threat to patient safety
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