Quality management of Medical Products
Patient Safety
Since patients safety and the safety for users, third parties and the environment have the highest priority our medical products must meet the requirements of Council directive 93/42/EEC during the production process.
We document this for our medical products with the CE mark of conformity. Our notified body inspects every year the approval of the CE mark of conformity.
For this, we implemented an integral quality management system which meets the requirements as specified in EN ISO 13585. In addition to the basic requirements as specified in EN ISO 9001, this standards provides further restrictive requirements. The objective of this standard is not a permanent improvement of processes but to document that the effectiveness of the quality management system is maintained.
Bio compatibility and Sterilization
All our medical products meet the requirements with regard to bio compatibility as specified in EN ISO 10993-1, depending on the specific purpose.
We deliver sterile products upon customer request. For this, we cooperate with partners who guarantee a validated EO-sterilization process as specified in EN ISO 11135-1 for the sterilization of medical products.
The following certificates are available for our products:
- Certificate of sterility in accordance with 556-1
- Certificate of Endotoxin Analysis (LAL-Test in accordance with EP-BE: Ph. Eur. 5 Chapter 2.6.14)
- Ethylene oxide and Ethylene chlorohydrine residual gas analysis according to EN ISO 10993-7
- Bio-burden determination in accordance with EP-ME: Ph. Eur. 5 Chapter 02/06/2012)
All materials and components which are used for the manufacture of our medical products meet the requirements as specified in EN ISO 10993-1 or USP class VI.
None of the components or materials used during our production process contain natural rubber or latex. All our medical products are free from phthalates which are categorized as carcinogenic, genotoxic or reproduction inhibiting substances as specified in category 1 or 2 according to Appendix I of Council Directive 67/548/EEC.
Packing and clean room monitoring
All materials used for packing our medical products meet the requirements specified in DIN EN ISO 11607 and DIN EN 868. We guarantee reproducible ambient conditions for our production process (clean room category D in accordance with EU Guide line GMP, Appendix 1 or as specified in US Federal Standard 209 E, Appendix 100.000 respectively, and ISO-class 8 in accordance with EN ISO 14644-1 standard). Our clean room monitoring is regularly carried out by a laboratory accredited by the German national regulatory authority ZLG.
We apply validated processes for the production of our products, for instance for bonded joints. Also, we use calibrated measuring and inspection devices for our products and processes.
Your Partner:
Business Unit Fiber Optics
Ilja Schenker
Manager Regulatory Affairs
ilja.schenker@leoni.com
