Medical Devices Regulatory support:
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ISO-13485 and CE marking certification
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FDA 510K and Establishment registration
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Grant of Manufacturing licenses and renewals
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Issue of state GMP certificate,
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Issue of free sale certificate
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Device master file preparation and maintenance
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Plant master file preparation and maintenance
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Cleaning method Validation Document Requirements and Method of Validation
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Issue NOC from DCGI
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Grant of Test License
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Issue of WHO GMP certificate
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Notified device evaluation
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Clinical Evaluation as per MEDDEV 2.7.1 Rev. 4
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Technical files preparation for CE marking
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Conduct of Clinical Investigations of medical devices as per ISO14155: 2011
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Medical Device Post Market Surveillance and Vigilance Requirements
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Design Control Documentation
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Design History File (DHF)
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Risk Analysis and Risk Management for all Classes of Medical Devices and IVDs as per ISO 14971 requirements.
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Clinical validations as per AAMI, BHS and ESH IP protocols
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Bio compatibility testing of Medical devices with GLP and NABL accredited laboratories
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For more information email us at info@pharexcelconsulting.com or contact us today.