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

Regulatory

• 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
• Notified Body interfacing   

​Quality Management Systems

• QMS, Quality Manual Implementation-ISO13485, 21CFR Part820, 11, 210, 211, MDR, ISO14971
• CAPA, Medical Device Reporting, Complaints
• Risk Management under ISO14971, Risk Management File, Planning, Report