Medical device – Sterilization
AL Engineering offers assistance on auditing and compliance in relation to sterilization of Medical Devices. Suppliers of sterilization services can be audited according to your audit plan or we can help you audit and search for alternative suppliers. We can audit according to ISO 11137, the standard for gamma/e-beam sterilization of medical device or ISO 11135, the standard for sterilization of Medical Device ethylen-oxide.
Therefore, we can assist you on the following areas within sterilization:
- GAP analysis of your procedures according to ISO 11137/ISO 11135
- Review of validation documentation (IQ/OQ/PQ).
- Segmenting of products in product families / patterns etc.
- Supplier audits
- Assistance on handling of non-conformities /audit responses.
Please contact Tina Linders for a non-committal talk about how we can make a difference for your company.
+45 2913 2445