Regulatory Affairs for Medical Devices

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Need assistance with regulatory issues for your medical device? We provide the direction you require to follow intricate regulation requirements.

It is difficult to separate quality control from regulatory issues. For this reason, MedWatch Global gives you everything you need.

Along with taking care of quality control, we also assist you with all aspects of the legal lifecycles for medical devices.

OVERVIEW OF OUR RA SERVICES

Vigilance and Regulatory Strategy with Clinical and Technical Services
i) Regulatory Stratagies
  • Clinical analysis, clinical research
  • Classification of medical devices
  • Getting in touch with the appropriate officials (FDA, Notified Bodies, and DRAP, etc.)
  • Regulatory filing
  • Management of programs and project
ii) Global submissions
  • Knowledge of emerging industries
iii) Post Market Regulatory
  • PMS/PMCF
  • CER Update
  • Upgrades & Variations
  • Report for EudaMed every year

WHY MEDWATCH GLOBAL?

MedWatch Global full circle Support
  • Product Formulation services
  • Clinical Intervention and regulatory affairs
  • Product licensing procedure
  • Manufacturing and design transfer
  • Training
  • ISO 13485:2016