Consulting and representation as a European Authorised Representative (E.A.R.) for medical device manufacturers in the EEA.
Mars Medical
Stuttgart (Landhausstraße 46) · Mumbai (SK Bole Road,lt. JSON-LD Mars Solutions)New on Amplifa
About Mars Medical
Mars Medical is a consulting company based in Stuttgart (Baden-Württemberg) that supports medical device manufacturers as a European Authorised Representative (E.A.R.) and as an EU Importer. The offering comprises three service levels: the Standard Service for devices already CE-marked and placed on the market in the EU, the Advanced Service for CE marking and market launch from countries outside the EU, and the Advanced Plus Service with support for product registration, clinical trials, incident reporting, and recall measures. Fast-Track support is offered for manufacturers affected by BREXIT and the MDR transition. Furthermore, Mars Medical supports the establishment of a Quality Management System via partners. The team has development experience in the fields of Gynecology, Urology, Cardiology, and Neurology, as well as in surgical instruments and implants for cosmetic and robotic surgery with a focus on minimally invasive procedures.
- Site
- Stuttgart
- Processes
- European Authorised Representative (E.A.R.) for Medical Devices, EU Importer Services, Fast-Track Support for manufacturers affected by BREXIT and the MDR transition, Standard E.A.R. Service (Device already CE-marked, additional/replacement representative), Advanced E.A.R. Service (CE marking, market entry from non-EU), Advanced Plus E.A.R. Service (Product registration, clinical studies, incident reporting,, Support with QMS setup via partners
- Materials
- Standard E.A.R. Service, Advanced E.A.R. Service, Advanced Plus E.A.R. Service, QMS Setup
- Certificates
- ISO 9001, ISO 13485
- Employees
- 2-10
- Industries
- Medical Technology, Gynecology, Urology, Cardiology, Neurology, Surgical Instruments/Implants
- 01
Consulting for product representation in the EU
- 02
Selection of service level (Standard, Advanced, Advanced Plus)
- 03
Regulatory representation as E.A.R. / EU Importer
- 04
Support with registration, clinical trials, and recalls
- 05
QMS setup via partners
Services
Standard E.A.R. Service
For devices already CE-marked and placed on the market in the EU; additional or replacement authorized representative.
Advanced E.A.R. Service
For devices outside the EU that are being prepared for CE marking and market entry in the EU.
Advanced Plus E.A.R. Service
Support for product registration, clinical studies, incident reporting, and recall support for devices in the development phase.
QMS Setup
Setup of a quality management system via established partners.
Locations
Stuttgart
DEHeadquarters, consulting as European Authorised Representative
Mumbai
INLocation according to JSON-LD (Mars Solutions)
Focus Areas
Inside the production
Industries
Additional services
Quality
Information regarding certifications or testing procedures is not available in the current sources. QMS setup is supported via partners.
| Evidence | Stuttgart |
|---|---|
| ISO 9001 | |
| ISO 13485 |