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
Quality
Management Systems
- 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