Certificates
Certificates are issued to Ardem Medikal, the owner of the MDtech brand. Registered name: Ardem Tıbbi Ürünler Medikal İthalat İhracat Turizm Otomotiv Gıda Sanayi ve Ticaret Limited Şirketi.
Management system certificates
- ISO 13485:2016Medical Devices - Quality Management SystemCertification body: IQRValid until: 16 Nov 2026Download PDF
- ISO 9001:2015Quality Management SystemCertification body: IQRValid until: 16 Nov 2026Download PDF
- ISO 14001:2015Environmental Management SystemCertification body: IQRValid until: 16 Nov 2026Download PDF
- ISO 45001:2018Occupational Health and Safety Management SystemCertification body: IQRValid until: 16 Nov 2026Download PDF
- ISO 22716:2013Good Manufacturing Practices (GMP)Certification body: GCR CERTValid until: 16 Nov 2026Download PDF
Product standard certificates
- ISO 11140-1:2015Sterilization chemical indicatorsCertification body: GCR CERTValid until: 16 Nov 2026Download PDF
- ISO 11140-4:2008Bowie-Dick test indicatorsCertification body: GCR CERTValid until: 16 Nov 2026Download PDF
- ISO 11607-1:2020Sterilization packaging materialsCertification body: GCR CERTValid until: 16 Nov 2026Download PDF
- ISO 15883-1:2010Cleaning indicators - general requirementsCertification body: GCR CERTValid until: 16 Nov 2026Download PDF
- ISO 15883-5:2021Cleaning indicators - soil testsCertification body: GCR CERTValid until: 16 Nov 2026Download PDF