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DE: Beratung Zulassung und Zertifizierung von Medizinprodukten EN: Consulting and Certification Medical Device
  • Medical Device
  • European Market
    • Medical Devices in the EU Market
    • Risk Class & Medical Device Classification in the EU
    • 1. CE Certification for Medical Devices
    • 2. Your EU Representative
    • 3. Storage & Fulfillment for Medical Devices
    • 4. Technical Documentation for MDR
    • 5. Post-Market Surveillance & Monitoring
  • Consulting
    • Risk Management System for Medical Devices
    • General Safety & Performance Requirements
    • Clinical Evaluation & Studies
    • Quality Management for Medical Device Manufacturers
    • Quality Management System ISO 13485 Compliance
    • Medical Device Consultant Training
    • Medical Software Application Certification
    • Cleaning & Sterilization Procedure
    • Differentiation Pharmaceutical and Medical Device Classification
    • IVD Consulting and Registration – In-Vitro Diagnostic
  • Resources
    • News
    • Download
    • Pictograms for Medical Devices
    • Medical Device Glossary
    • Frequently Asked Questions
  • About us
  • Contact
  • Medical Device
  • European Market
    • Medical Devices in the EU Market
    • Risk Class & Medical Device Classification in the EU
    • 1. CE Certification for Medical Devices
    • 2. Your EU Representative
    • 3. Storage & Fulfillment for Medical Devices
    • 4. Technical Documentation for MDR
    • 5. Post-Market Surveillance & Monitoring
  • Consulting
    • Risk Management System for Medical Devices
    • General Safety & Performance Requirements
    • Clinical Evaluation & Studies
    • Quality Management for Medical Device Manufacturers
    • Quality Management System ISO 13485 Compliance
    • Medical Device Consultant Training
    • Medical Software Application Certification
    • Cleaning & Sterilization Procedure
    • Differentiation Pharmaceutical and Medical Device Classification
    • IVD Consulting and Registration – In-Vitro Diagnostic
  • Resources
    • News
    • Download
    • Pictograms for Medical Devices
    • Medical Device Glossary
    • Frequently Asked Questions
  • About us
  • Contact

Downloads

  • Certificate TÜV (Technical Inspection Association): Consulting in the context of Quality Management Systems for Medical Devices
  • Certificate TÜV (Technical Inspection Association): Production and Sale of Vaginal Pessaries. Storage of Sterile Dental Implant Systems, Instruments and Dental Accessories on Behalf.
  • - Checklist for Basic Services and Security Requirements (GRuSuLa)
WQS Download

Support for US companies to enter the European market. EU Rep, Certification, QM System, Technical Documentation, support of the Procedure, selection of a Notified Body, support of the Certification Procedure, preparation of a Clinical Evaluation, support of Clinical Studies, including the Logistical Concepts.

HOTLINKS

  • Medical Device
  • General Safety & Performance Requirements
  • Medical Devices in the EU Market
  • Pictograms for Medical Devices
  • Risk Class & Medical Device Classification in the EU
  • Frequently Asked Questions
  • Medical Device
  • General Safety & Performance Requirements
  • Medical Devices in the EU Market
  • Pictograms for Medical Devices
  • Risk Class & Medical Device Classification in the EU
  • Frequently Asked Questions

Contact

WQS Management Consultants Inc
136 4th Street north, Suite 201
St Petersburg, Florida 33701

Telefon: (925) 212-7683
Email: werner@us.wqs.de
Web: us.wqs.de

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