Qualitätsmanagementsystem

DIN EN ISO 13485 : 2016

• German (212 kB, PDF)
• English (206 kB, PDF)

MDR DQS certificates

• DQS Annex IX, Chapter I and III of the Regulation, MDR 2017/745 (266 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)

MDR DNV MEDCERT certificate

• English (2.25 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)

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)