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DE: Beratung Zulassung und Zertifizierung von Medizinprodukten EN: Consulting and Certification Medical Device
  • Medical Device
    • Medical Device Glossary
    • Risk Classification
    • Differentiation Pharmaceutical and Medical Device Classification
  • Registration
    • Medical Devices in the EU Market
    • International Approval for Medical Devices
  • Consulting
    • CE Certification for Medical Devices
    • Technical Documentation under MDR
    • Risk Management System for Medical Devices
    • Quality Management for Medical Device Manufacturers
    • Quality Management System ISO 13485 Compliance
    • General Safety & Performance Requirements
    • Clinical Evaluation & Studies
    • Post-Market Surveillance & Monitoring
    • Cleaning & Sterilization Procedure
    • Storage & Fulfillment for Medical Devices
    • Medical Software Application Certification
    • IVD Consulting and Registration – In-Vitro Diagnostic
  • Resources
    • News
    • Pictograms for Medical Devices
    • Medical Device Consultant Training
    • Download
    • Frequently Asked Questions
  • About WQS
    • Our Company
    • Job Openings
  • Contact
  • Medical Device
    • Medical Device Glossary
    • Risk Classification
    • Differentiation Pharmaceutical and Medical Device Classification
  • Registration
    • Medical Devices in the EU Market
    • International Approval for Medical Devices
  • Consulting
    • CE Certification for Medical Devices
    • Technical Documentation under MDR
    • Risk Management System for Medical Devices
    • Quality Management for Medical Device Manufacturers
    • Quality Management System ISO 13485 Compliance
    • General Safety & Performance Requirements
    • Clinical Evaluation & Studies
    • Post-Market Surveillance & Monitoring
    • Cleaning & Sterilization Procedure
    • Storage & Fulfillment for Medical Devices
    • Medical Software Application Certification
    • IVD Consulting and Registration – In-Vitro Diagnostic
  • Resources
    • News
    • Pictograms for Medical Devices
    • Medical Device Consultant Training
    • Download
    • Frequently Asked Questions
  • About WQS
    • Our Company
    • Job Openings
  • Contact

Category: Kategorie 1

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.

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