3Fold Brochure A4 2nd - Evolution Medtec2019/12/03 · MDD; MDR and AIMD RCC Starting from...
2
ENABLING THE FUTURE Class III Active Implant AIMD ISO 13485 device Full scale development of a complete system for cutting edge treatment of severe brain disorders ISO 13485 device Evolution Medtec Srl 1 Decembrie 1918 Blvd., No 1G 032451, Bucharest 3, Romania [email protected] www.evomedtec.com YOUR IDEA Feasibility and Analysis Demonstrator Development V-Modell Prototyping V&V System Integration Industrialization Pre-Series Test system Development – IQ; OQ; PQ ISO 13485 EN 62304 EN 60601 ISO 14971 MDD; MDR and AIMD RCC
Transcript of 3Fold Brochure A4 2nd - Evolution Medtec2019/12/03 · MDD; MDR and AIMD RCC Starting from...
ENABLING THE FUTURE
Class III
Active ImplantAIMDISO 13485 device
Full scale developmentof a complete system forcutting edge treatment ofsevere brain disordersISO 13485 device
Evolution Medtec Srl1 Decembrie 1918 Blvd., No 1G032451, Bucharest 3, Romania
www.evomedtec.com
YOUR IDEA
Feasibility and Analysis
Demonstrator
Development
V-Modell
Prototyping
V&V
System Integration
Industrialization
Pre-Series
Test system Development – IQ; OQ; PQ
ISO 13485
EN 62304
EN 60601
ISO 14971
MDD; MDR and AIMD
RCC
Starting from innovative ideas and application focused technology and from project description
System development composed of implant, remote control programming unit and Android based App for physician
Full scale development of implanted electronic Hardware and Software
Final system, fully documented (DHF, DMR, DHR) ready for manufacturing
Development of the mechanical parts, embedding the electronic module and prepare industrialization
