Microbiology Lab for Implants (Plates and screws)

The main point here is that these medical devices must be sterile. So I assume they are produced in a cleanroom. Microbiology requirements then include the following:

• Microbiology monitoring of the environment (surfaces, air, workers hand, machines that are used in the cleanroom)
• Bioburden before sterilization so that you know what is the microbiological load of your products to know which sterilization method to choose
• Testing the sterility of your product after the sterilization

All of this is stated in the following standard:

• EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

The microbiology laboratory for performing all this work must be accredited. It is stated in the MDR 2017/745, Article 106 - Article 106 – Provision of scientific, technical, and clinical opinions and advice – that the EU Commission designated the expert laboratories. Accreditation is one way how a laboratory can be designated.

For more information, please see:

• EU MDR Article 106 - Article 106 – Provision of scientific, technical and clinical opinions and advice https://advisera.com/13485academy/mdr/provision-of-scientific-technical-and-clinical-opinions-and-advice/