Medical Devices Regulatory support:

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  • ISO-13485 and CE marking certification

  • FDA 510K and Establishment registration

  • Grant of Manufacturing licenses and renewals

  • Issue of state GMP certificate, 

  • Issue of free sale certificate

  • Device master file preparation and maintenance

  • Plant master file preparation and maintenance

  • Cleaning method Validation Document Requirements and Method of Validation

  • Issue NOC from DCGI

  • Grant of Test License

  • Issue of WHO GMP certificate

  • Notified device evaluation

  • Clinical Evaluation as per MEDDEV 2.7.1 Rev. 4 

  • Technical files preparation for CE marking

  • Conduct of Clinical Investigations of medical devices as per ISO14155: 2011

  • Medical Device Post Market Surveillance and Vigilance Requirements

  • Design Control Documentation 

  • Design History File (DHF)

  • Risk Analysis and Risk Management for all Classes of Medical Devices and IVDs as per ISO 14971 requirements.

  • Clinical validations as per AAMI, BHS and ESH IP protocols

  • Bio compatibility testing of Medical devices with GLP and NABL accredited laboratories

 

For more information email us at info@pharexcelconsulting.com or contact us today.