Validation-non Product Software

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

Medical Device Software, Embedded Software 

• Subject Matter Expert on implementing SDLCs for Agile/TIR45 under SIMD IEC62304,SAMD IEC 82304, ISO14971,
• Complete Validation of SaMD (Software as a Medical Device) and SIMD 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 

• 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 14971:2019, Hazard List, Risk Management Plan, Report
• Labeling-IFUs, Serialization, website content 
• 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, Action Plan, and implementation
• MDD, MDR- Implementation of Technical File 
• MDR preparation for notified body audits for CE marking 
• TUV-SUD Notified Body interfacing   

• QMS EU MDR and FDA Policies, Procedures, and Work Instructions
• Quality Manual Implementation-ISO13485, 21CFR Part820, 11, 210, 211, MDR, ISO14971
• CAPA, Medical Device Reporting, Complaints