Validation-non Product Software

  • Computer System Validation under FDA Software Guidance and GAMP5 for SaS (Software as a Service), CSA (Computer Software Assurance) for Production and Quality Systems 
  • Generation of GXP/Part 11 Assessments, Software Classification, Validation Plans SRS,SDS,Test Procedures, IQ,OQ,PQ-as applicable, execution, reports  


Medical Device Software, Embedded Software 

  • Subject Matter Expert on implementing SDLCs for Waterfall, Agile/TIR45 under IEC62304,ISO14971
  • Complete Validation of SaMD (Software as a Medical Device) and Embedded Medical Device-Development Plan, SCM Plan, Risk Management Plan, Usability Plan, Trace Matrix, SRS, SDS, VP, VR
  • Software Quality Compliance of Development, Verification Activities, Deliverables required by IEC62304, ISO14971
  • ScrumMaster. Former Software Developer


 Product Development

  • Project Management
  • Design Controls, Change Management under ISO 13485 and 21 CFR Part 820-Reviews,DHF, Transfer, DMR
  • Risk Management File under ISO 14971-dFMEA, pFMEA, uFMEA, Hazard List, Risk Management Plan, Report
  • Labeling  
  • Usability/Human Factors Engineering File-Risk Assessment, protocols, execution, report
  • Electronic/Electrical design
  • Mechanical design


Testing-Non Clinical

Performed Summative Usability Study under IEC62366, Human Factors. Created Usability Engineering File 

Coordination with labs for acquiring the following test reports:

  • Electrical devices-ISO 60601
  • Biocompatibility under ISO 10993
  • Cytotoxicity 
  • Sensitization
  • Low Level Disinfection
  • Shelf Life
  • Packaging Validation



  • FDA 510K, Modular PMA and DeNovo
  • IDE (Investigational Device Exemption), Breakthrough Device
  • MDD to MDR gap assessments
  • MDD, MDR- Implementation of Technical File 
  • MDR preparation for notified body audits for CE marking and product certificate
  • TUV-SUD Notified Body interfacing   
Quality Management Systems  
  • QMS, Quality Manual Implementation-ISO13485, 21CFR Part820, 11, 210, 211, MDR, ISO14971
  • CAPA, Medical Device Reporting, Complaints