MDSS CH GmbH

General Manager

QDC GmbH

Owner

Hörwerkstatt

Wir möchten Ihnen die Freude am Hören schenken. Dies erreichen wir mit top Produkten zu fairen Preisen, einem kundenfreundlichen Service und sehr kurzen Lieferzeiten. Dies wiederspiegelt sich in den über 1000 Bewertungen auf Trusted Shops mit 4.89 (Stand 02.09.2019)

ZERAMEX

"Finding solutions that are as simple as possible and as complex as necessary"

- CER according to MEDEV 2.7.1 rev. 4

- Risk management (ISO 14971)

- Usability

- Biocompatibility reports (ISO 10993)

- Cleaning validations

- Reprocessing validations

- Transport and packaging validations

- Sterilisation validations (ISO 17665) & shelf life

- GAP analysis MDD / MDR, planning and putting in place relevant processes and measures, setting up transition plan. 

- Compilation of technical documentation for class Ir products under MDR

- Compilation of technical documentation for class IIa / IIb under MDR 

- Planning of emergency procedure in case of failure of the institutional agreement (INSTA) and subsequent termination of the MRA between Switzerland and the EU 

- Integration new production facilty in existing QMS with all relevant validations

- Country specific registrations (US / EU)

- QMS under ISO13485 and 21 CFR Part 820

Leiter Quality Management & Regulatory Affairs

Development of two metal free screw retained, two piece dental implants and successful launch in the market(EU & US). Three patents filed, planning and ramping up new, fully functional production facility, development of efficient machining strategies for fully sintered and HIPped zirconia (ATZ and TZP)

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