Visamed
VISAMED is a highly specialized consulting company providing a full range of services to medical device companies worldwide. With an experienced and dedicated team based in Karlsruhe, Germany, and Barcelona, Spain, VISAMED offers expertise in medical device regulation, quality systems, product development, and acts as a European Authorized Representative. The company aims to support clients in achieving regulatory compliance, market access, and product development through comprehensive consulting, registration, and regulatory services.
Industries
Nr. of Employees
small (1-50)
Visamed
Services
Consulting to define regulatory strategy, identify applicable standards, prepare technical files/dossiers, and support submissions for CE marking, Canadian licences and US filings (IDE, PMA, 510(k)).
Act as EU Authorized Representative including EUDAMED/company registration, maintaining technical documentation for inspections, and coordinating incident and FSCA reporting.
Set up or adapt QMS to meet ISO 13485 and regional regulations, deliver staff and management training, conduct internal audits and implement CAPA systems.
Prepare CEP/CERs compliant with MDR, perform literature-based clinical evaluation, design and manage clinical investigations including investigator selection, ethical approvals, monitoring and data management.
Verify and validate medical software and develop medical mobile apps with compliance to IEC 62304 and relevant regulatory requirements; support localization and software lifecycle documentation.
Develop testing strategies for in vitro and in vivo models, coordinate bench testing and animal studies to support design verification and regulatory filings.
Consulting to define regulatory strategy, identify applicable standards, prepare technical files/dossiers, and support submissions for CE marking, Canadian licences and US filings (IDE, PMA, 510(k)).
Act as EU Authorized Representative including EUDAMED/company registration, maintaining technical documentation for inspections, and coordinating incident and FSCA reporting.
Set up or adapt QMS to meet ISO 13485 and regional regulations, deliver staff and management training, conduct internal audits and implement CAPA systems.
Prepare CEP/CERs compliant with MDR, perform literature-based clinical evaluation, design and manage clinical investigations including investigator selection, ethical approvals, monitoring and data management.
Verify and validate medical software and develop medical mobile apps with compliance to IEC 62304 and relevant regulatory requirements; support localization and software lifecycle documentation.
Develop testing strategies for in vitro and in vivo models, coordinate bench testing and animal studies to support design verification and regulatory filings.
Expertise Areas
- Regulatory strategy and submissions (EU, US, Canada)
- Quality management systems (ISO 13485) implementation
- Clinical evaluation and clinical investigation management
- Medical device software validation and IEC 62304 compliance
Key Technologies
- IEC 62304 (medical software lifecycle)
- ISO 13485 (QMS)
- ISO 14971 (risk management)
- EN 62366 / EN 60601-1-6 (usability engineering)