Sample Projects
Design Project Samples
New Medical Device Feasibility Assessment.Show details.
Created Usability File, Risk Management File and Software Development Technical File for IEC 60601-1 3rd Edition submission. Show details.
Conducted IEC62304 Software Validation and Created Software Development Technical File for IEC 60601-1 3rd Edition submission. Show details.
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Manufacturing Project Samples
Created protocols for and conducted IQ, OQ and PQ for Medical Device manufacturing equipment. Show details.
Automated Equipment Risk Management and Software Validation. Show details.
Updated PFMEA to support manufacturing startup on new Medical Device. Show details.
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Regulatory & Standards Compliance Project Samples
Developed and implemented FDA QSR/ISO 13485 compliant Quality System for startup company. Show details.
Obtained 510(k) Market Clearance for new Medical Device. Show details.
Created Technical File for CE Mark submission. Show details.