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Useful Links

  1. Useful Links

National and International Regulatory Authorities

  • TITCK (Turkish Medicines and Medical Devices Agency)  
  • FDA (U.S. Food & Drug Administration) 
  • ANZCTR (Avustralian New Zealand Clinical Trials Registry) ​​
  • KAP (Clinical Trials Portal) ​​​
  • EU Clinical Trials Register

 

Guidances and Regulations

  • Good Clinical Practice Guidance (GCP)
  • Guidance for Training Programming and Evaluation in Clinical Research
  • MEDDEV 2.12/2 rev 2 Guidance Document Medical Devices - Market Surveillance - Post Market Clinical Follow-up Studies
  • Medical Device Regulation (MDR) 2017/745
  • MEDDEV 2.7.1 Rev 4 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies
  • WMA Declaration of Helsinki

 

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  • Clinical Investigation for Medical Devices – The Clinical Investigation Plan
  • Biological evaluation of medical devices
  • SCHEER 2024 CMR ED Phthalate General Overview
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  • Chemical Characterization – Worst-case chemical release
  • Chemical characterization – Chemical equivalence
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