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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.