Solnovis GmbH


    • Company type:
      • Manufacturer
      • Research & Development
      • Service Provider
    • Year founded:
    • 2006
    • Employees (at the site):
    • not available
    • Turnover range:
    • <5m EUR
    • Products/services:
    • Solnovis - Medical Engineering Experts
      Our customers appriciate our expertise in following areas:
      Documentation, design documentation for medical devices, regulatory afairs (Europe, USA and international), design and manufacturing of components for medical devices, training and consulting (e.g. quality management, certification and compliance, harmonized standards)

    • Core competencies:
    • Development:
      Hard- &amp; software development; mechanical design; prototype construction; regulatory testing (e.g. consulting in EMC design &amp; testing acc. to IEC 60601-1-2); verification &amp; validation; development doc. (DHR / DHF); automation with CAN technology; LED &amp; Laser technology; optics design; safety-relevant components
      Supply Chain Management; analysis &amp; definition of manufacturing processes; manufacturing of assemblies &amp; systems (small &amp; large-scale production); assurance of traceability; full quality assurance
      Regulatory Affairs:
      Consulting on QM (EN ISO 13485, EN ISO 9001, 21CFR820); definition &amp; optimization of SOPs; preparation for external audits (FDA, Notified Bodies, authorities); preparation &amp; carrying out of internal audits; licensing of medical products (CE, USA, int.); risk management acc. to ISO 14971; software doc. acc. to IEC 62304; usability evaluation acc. to IEC 62366; Safety of medical devices acc. to IEC 60601-1-ff and IEC 60601-2-ff

    • Language skills:
    • English
    • Key Tech / section:
      • Medical Technology: Medical and electro-medical instruments and devices
    • Industries NACE:
      • 70: Activities of head offices; management consultancy activities
    • Certification:
    • Certified quality management system according to ISO 9001 and ISO 13485; implemented quality management system fullfills requirements according to 21CFR820

    • Sales markets - target industries:
    • Hersteller von Medizinprodukten
    • Sales markets - target countries:
      • Germany
    • Cooperation offers:
    • not available
    • Contact person:
    • Daniel Haberer (Mr.)
      - Management
      - Research & development
      - Cooperation