STANISLAUS FRANCIS
IVD Quality Assurance & Regulatory Affairs
Chennai,TN
Summary
I am a professional with more than 12 years of experience in In-vitro diagnostics in the field of Quality, Testing, and Regulatory affairs. Experienced in EU-IVDR documentation like protocol writing, Performance Evaluation Report (PER), Clinical Evaluation Report (CPR), Literature Review Report (LRR), Scientific Validity Report (SVR) etc. Experienced in medical device complaint Handling as per 21CFR803 requirement. Worked in Intake, Investigation, & Regulatory reporting part. Good Knowledge on quality management ISO 13485, ISO 15189) and Regulatory requirements for medical and In-vitro diagnostic device -EU-IVDR, USFDA 21CFR820 Verify and validated various global leading manufactures IVD instruments as per CLSI standards (EP 05, EP06, EP07, EP09, EP17, EP25) and ISO standards (ISO20916:2019) for regulatory submission of EU IVDR and FDA 510(k) submission. worked in both referral lab and hospital setups played various roles like Lab Supervisor, Quality In-charge & NABL ISO 15189 Internal Auditor.
Overview
14
14
years of professional experience
6
6
Certifications
2
2
Languages
Work History
Senior Technical lead
HCLTech
10.2024 - Current
- Led and mentored a team of 10 technical professionals, providing expert guidance across microbiology and IVD product lines to ensure efficient project execution and regulatory compliance.
- Prepared and reviewed stability reports for regulatory documentation, aligning with global standards such as ISO 13485, ISO 15189, and EU Regulation 2017/746.
- Conducted technical investigations for microbiology product complaints, authored customer response letters, and ensured timely resolution, aligned with quality and regulatory expectations.
- Managed transport follow-ups for PPM products, ensuring traceability, and using the data for complaint investigation.
- Compiled and analyzed post-market surveillance (PMS) reports for IVD microbiology products, contributing to continuous product improvement and risk mitigation.
- Actively contributed to cross-functional initiatives including IPRB (Intellectual Property Review Board), VC (Value Creation), and Six Sigma projects, driving quality and process excellence.
- Participated in monthly audits for project monitoring and compliance tracking, supporting internal and external audit readiness.
- Engaged in continuous learning through technical and regulatory trainings, fostering a culture of knowledge sharing and professional development.
- Spearheaded client communications, including business proposal development, case study preparation, and representation during client visits, showcasing technical capabilities and fostering trust.
Lead Analyst- IVDR & MDR
HCL
11.2021 - 10.2024
- Actively involved in preparing IVDR documentation to support the transition from IVDD to IVDR, ensuring alignment with EU regulatory requirements.
- Reviewed and compiled regulatory submissions for FDA 510(k) applications, contributing to successful clearance of IVD devices.
- Executed and completed key deliverables for CE marking activities in accordance with the IVD Directive, supporting market access in the EU.
- Prepared and maintained comprehensive Technical Documentation for client products, ensuring readiness for audits and regulatory reviews.
- Conducted analytical performance studies following CLSI standards for both EU IVDR and FDA 510(k) submissions.
- Prepared regulatory assessments for proposed changes to marketed devices, including Literature Review Report(LRR) and Performance Evaluation Reports (PER).
- Performed data analysis based on performance evaluation tests to support product claims and regulatory filings.
- Reviewed clinical study protocols, clinical study reports, and supporting documentation to guide study planning and interpretation.
- Authored Performance Evaluation Reports (PER) for CE marking, integrating analytical and clinical data to demonstrate product safety and effectiveness.
- Executed Clinical Performance Study (CPS) activities in compliance with ISO 20916, ensuring robust clinical evidence generation.
- Developed study protocols and data management plans for CPS activities, coordinating with cross-functional teams and external partners.
- Served as Post-Market Surveillance (PMS) Lead, overseeing medical device reporting activities and ensuring timely submission of vigilance reports.
- Experienced in using TrackWise for complaint handling and documentation, including management of litigation-related complaints.
IVDR- Technical lead
Kapston FM
01.2021 - 10.2021
- Project (IVDR)– Deployed in HCL
- Perform the gap assessment and remediation against regulatory documents and standard documents.
- Do performance evaluation of IVD medical device.
- Assist on internal regulatory audits and regulatory reporting.
- Preparation of regulatory assessment on proposed changes to marketed device.
- Do data analysis based on performance evaluation test.
- Review clinical diagnostic protocols, clinical study reports, and other documents that support clinical study planning and interpretation.
Medical Lab Technologist-Biochemistry
Gleneagles Global Health City
01.2017 - 01.2021
- Work under supervision of HOD in clinical biochemistry to help with the preparation of specimen for biochemical measurement.
- Receive, Acknowledge and Evaluate the specimen suitability for analysis.
- Prepare, aliquot and store reagent, Calibrators & controls.
- Process and document the internal & external quality control.
- Perform routine test using established standard operating procedure and inform IP/OP critical reports to consultants.
- Handling various biochemistry and immunoassay automated analyzer for test execution.
- Troubleshooting the biochemistry assay/device when encounter the error.
- Transfer the results from LIS to HIS & generate report from HIS.
- Indent the stock requirement form the store and maintained minimum stock at lab.
- Prepare the monthly statistical data as instruction and advice from HOD.
Lab In-charge And Technical Coordinator
Winpath Lab & Healthcare
06.2012 - 09.2016
- Prepare specimen for analysis and established proper chronological priorities in testing.
- Identified abnormal test results and referred them to the pathologist for further review.
- Carefully interpret test results for accuracy and clinical relevance.
- Properly calibrated and adjusted malfunctioning equipment to ensure precise test results.
- Performed both routine and emergency maintenance on laboratory instrument.
- Worked in various department like Biochemistry, Hematology, Pathology, Serology, Immunoassay, Microbiology.
- Performed diagnostic and therapeutic laboratory procedures.
- Quickly responded to and resolved all Customer service issues in a timely manner.
- Prepare statistical data for monthly and annual reports.
- Also maintaining the purchase department, Prepared purchase orders for supplier.
Education
Bachelor of Science - Biotechnology
A.V.C. COLLEGE (Autonomous)
Mayiladuthurai, TN01.2010
Master of Science - Medical Laboratory Technology
Loyola College (Autonomous)
Chennai01.2012
Skills
Microsoft Office
Trackwise
Medical Writer
Regulatory Documentation
Lab Medicine
Microbiology
IVD Test Execution
IVD Report Interpretation
Literature Review
Protocol writing
IVD Device Troubleshooting
Six Sigma
Device Verification & Validation
IVD Calibration &QC
Biostatistics/ Data Analysis
Complaint Handling
Certification
ISO 13485:2016 Quality management system Jan 2022
Interests
Cooking, Cycling
Accomplishments
- Knowledge champion for IVDR project
- Knowledge Champion for IVD sustenance Project
- Process Champion for IVD Center of Excellence
Disclaimer
Chennai, December 5, 2025
Timeline
Senior Technical lead
HCLTech
10.2024 - Current
Lead Analyst- IVDR & MDR
HCL
11.2021 - 10.2024
IVDR- Technical lead
Kapston FM
01.2021 - 10.2021
Medical Lab Technologist-Biochemistry
Gleneagles Global Health City
01.2017 - 01.2021
Lab In-charge And Technical Coordinator
Winpath Lab & Healthcare
06.2012 - 09.2016
Master of Science - Medical Laboratory Technology
Loyola College (Autonomous)
Bachelor of Science - Biotechnology
A.V.C. COLLEGE (Autonomous)