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Home » Medical Devices » MDR | Medical device certification

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1. DOCUMENTS

Guide for medical device manufacturers

Guide for SW MEDECA

Methodological guide- Medical devices classification rules

Methodological guide – Rules for the selection of conformity assessment procedure

Procedure for submitting an application for a medical device conformity assessment

Price list

The CMI General Terms and Conditions

 

2. FORMS

The Non-binding Inquiry electronic form

Initial Application form for Medical Device Conformity Assessment

  • Calibration
  • Verification
  • Notified Body Services
  • Other services
  • Czech national standards
  • Medical Devices
    • MDR | Medical device certification
      • ➜ GETTING STARTED WITH CERTIFICATION
      • ➜ GET A QUOTE
      • ➜ SUBMIT AN APPLICATION
      • ➜ POST-MARKET SURVEILLANCE
      • NEWS
      • WHY CHOOSE US
      • CONFORMITY ASSESSMENT SCOPE
      • PRICE LIST
      • REQUIREMENTS PLACED ON MANUFACTURERS
      • PREPARATION FOR THE CONFORMITY ASSESSMENT PROCESS
      • LODGING OF NON-BINDING INQUIRY AND APPLICATION
      • FAQ
      • DOWNLOAD
      • CONTACT US
      • VIDEO
    • ISO 13485 | Quality management system certification
  • National Measurement system
  • International cooperation
  • Science and research

Český metrologický institut, Okružní 31, 638 00 Brno • IČ: 00177016 • DIČ: CZ00177016  

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