Skip to content

Medical Devices

Quality Control Testing for Medical Devices

Consistency, safety and quality of medical device materials and products is vital for any manufacturer. At Lucideon we can help you to maintain control of the quality of your product and process and quickly identify and resolve issues.

If you want to:

  • develop a quality assurance program
  • ensure product and material consistency and performance
  • test raw materials or materials from a new supplier
  • satisfy and validate in-house quality control protocols
  • receive regulatory approval
  • review your testing regimes and close any gaps for regulatory approval

Then Lucideon can provide high quality, reliable, fast and cost effective testing to meet your needs.

Lucideon will work with you on a batch-to-batch basis or as part of your long term R&D project to meet your QC needs.

In the UK Lucideon is a UKAS-accredited testing laboratory (No. 0013) and our Pharmaceutical/GMP Laboratories hold an MHRA Certificate of GMP Compliance (No. UK GMP 43644 Insp GMP/IMP 43644/10698843-0005, Dated:28/07/2020) for contract QC Testing of Human and Veterinary Medicines. The Lucideon Pharmaceutical/GMP Laboratories also hold a current FDA Certificate of Registration and were successfully inspected by FDA in Sep-2019.

In the US Lucideon is Nadcap-accredited and has 10 CFR 50 Appendix B Quality Assurance accreditation.

Related White Papers

Medical device cleanliness validation
Medical Devices - Cleanliness Validation

Residues on the surface of medical devices can cause implant failure and poor device performance

Design Optimisation in Medical Devices: Materials Matter

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

Ensuring Reliable Performance from Ceramic Components in Medical Applications

This white paper highlights some of the testing involved in ISO 13356 and discusses how recent and ongoing research into ceramic processing provides opportunities to meet product improvement challenges