Qualitätsmanagementsystem

ISO 13485 (DQS)

• Deutsch (178 kB, PDF)
• Englisch (183 kB, PDF)

ISO 13485 (DNV MedCert)

• Englisch (6.52 MB, PDF)

MDR DQS certificates

• DQS Annex IX, Chapter I and III of the Regulation, MDR 2017/745 (196 kB, PDF)

Product certificates according to article 52(4) subparagraph 2, (EU) 2017/745 MDR

• Reusable Surgical Instruments in Direct Contact With Central Nervous System (Class III) (223 kB, PDF)
• CapFlex Prosthesis (Class III) (93 kB, PDF)

MDR DNV MEDCERT certificate

• DNV Medcert Anex IX, Chapter I and III of the Regulation, MDR 2017/745 (13.14 MB, PDF)

Product certificates according to article 52(4) subparagraph 2, (EU) 2017/745 MDR

• DVN Medcert Class III MDN 1102 | TMJ Prosthesis | ThreadLock | maxDrive (1.11 MB, PDF)
• DNV Medcert Class III MDN 1102 | Resorb X® (4.14 MB, PDF)
• DNV Medcert Class IIb MDN 1102 | marPOR | Smart Orbital Implant (742 kB, PDF)
• DNV Medcert Class III MDN 1102 | HBS 2 Resorb Mg (2.20 MB, PDF)
• DNV Medcert Class III MDN 1102 | UHP (1.21 MB, PDF)

MDD DQS- Gebrüder Martin certificates

• DQS Annex II of Council Directive 93/42/EWG (0.97 MB, PDF)
• DQS EC Design Examination Certificate (Resorbable Implant System Resorb X®) (403 kB, PDF)
• DQS HBS 2 Resorb Mg (302 kB, PDF)
• Confirmation letter certificate (177 kB, PDF)

MDD DQS- KLS Martin GmbH + Co. KG certificate

• DQS Annex II of Council Chapter 93/42/EWG (755 kB, PDF)
• Confirmation letter certificate (176 kB, PDF)