Radhika Devi Email & Phone Number

Bengaluru, Ka, In

Bengaluru Area, India

• Worked with Ultrasound and SaMD products. Managed both product, systems, and medical device software. Experienced in both waterfall and Agile working models.• Supported strict regulatory adherence to industry standards such as IEC 62304, IEC 82304, IEC 80801-1, and IEC 62366 standards in product development.• Proactively collaborated on Design FMEA to pinpoint CTQ and CTS for patient safety• Partnered with medical affairs experts to assess the risk of medical devices and their mitigation to weigh the benefit-risk determination per ISO 14971.• Collaborated with other departments such as engineering and production for process improvements.• Established metrics including 'Automation test coverage,' 'Complaint rate,' 'Defect escape,' 'Security incidents,' and 'Say-Do ratio' to evaluate overall effectiveness.• Exhibited expertise in Philips standards and processes to support external audits (MDSAP certification, EU MDR notified body audits, L2 audits, Unannounced audit).• Engaged in critical project evaluations focusing on quality enhancement• Guaranteed full compliance in the end-to-end CAPA process to ensure on-time completion of investigation, implementation, effectiveness check, and closure to contribute to the quality KPIs.• Provided subject matter knowledge on tool validation and implemented safety, security, and privacy assessments in the in-house built Tool Design & Development process.• Established the comprehensive Operations validation process in the SaMD products.• Conducted thorough impact analyses for design changes in products• Managed Ultrasound device lab to adhere to PC-PNDT regulation and ensured calibration compliance of all lab use equipment, phantoms, and process validation checks.• Ensuring the clinical safety of an ultrasound product before deploying it in clinical studies, as per the Organization's clinical study process.

Bengaluru Area, India

• Managed a range of medical device products include ECG, Patient monitoring, NIBP, Defibrillators, Surgical X-ray.• Independently managed interactions with notified bodies to secure product certification and spearheaded coordination of certification body audits to retain the QMS certification.• Successfully led cross-functional team to achieve a 30% reduction in compliance related deviations over a 12 month period by implementing a robust EU MDD training program and enhancing SOP documentation, ensuring adherence to EU market regulations. • Trained the Sales team on checking the authenticity of a CE mark which helped in winning Government tenders • Appraised top management on Quality Management performance and presented findings at the Management Review Meeting, emphasizing growth opportunities.• Demonstrated technical proficiency for CE marking of medical devices in compliance with EU MDD (93/42/EEC) and IVDD (98/79/EC).• Ensured medical device and IVD products met all necessary requirements under EU directives through comprehensive technical file preparation, including Clinical Evaluation Report.• Lead the internal audit team and conducted internal audits on various functions in compliance with MDSAP, ISO 9001, ISO 13485, US FDA 21CFR Part 820, MDD 93/42/EEC, IVDD 98/79/EC.• Cultivated strong relationships with suppliers for virtual medical device manufacturing• Guaranteed regulatory compliance with IEC 60601-1 series from the time of product development.• Resolved conflicts between team members in an effective manner.• Organized training sessions for new hires to familiarize them with the Company's Quality policies, Quality processes, and made them understand the impact of their role in product quality.• Enhanced business reach and entered new markets through effective regulatory strategy development.• Established processes for Post-Market Surveillance.

Hyderabad Area, India

• Managed semi and fully automated immunoassay devices (A Laboratory use IVD product), Special stains, Immunoassays.• Lead the design verification and validation in product realization of medical devices.• Assessed implications of product design changes.• Served as Process Consultant on multiple design projects• Managed CAPA processes, including monitoring and closure.

Hyderabad Area, India

• Implemented procedures to enhance device monitoring accuracy during the cold chain management.• Handled customer complaints, ensuring timely closures, and routed complaints to the investigation cell when necessary.• Reviewing Device History Records to maintain finished goods quality.• Ensured precise calibration of production measuring and monitoring equipment.• Facilitated process assessment checks within the organization via internal audit.

Coimbatore, Tamil Nadu, India

Assisted in research on Computational Drug Designing Homology Modeling and Protein Ligand interaction to identify potential inhibitor for E1 Protein of Chikungunya”. o Carried out computational analysis o Compared structural stability and thermodynamic analysis o Computed interaction potential energy of each of the proteins and their molecule using molecular modelling techniqueProject advisor for 18 undergraduate students, providing guidance in project work, preparing thesis and publicationsPublications made:1. “Pre-transcriptional gene silencing technique for controlling skin cancer”, International Journal of Pharmaceutical Sciences and Research, IJPSR, Vol. 2(5), pp. 1293-1297, 20112. Homology Modeling and Protein Ligand interaction to identify potential inhibitor for E1 Protein of Chikungunya”

M.Tech, Biomedical Engineering, First Class With Distinction

Activities and Societies: Comuputational engineering and networking, Amrita Biomedical EngineeringWorked as Project Co-ordinator under.

B.Tech, Bioengineering, First Class With Distinction

Activities and Societies: Active member of department society BE@S

Maths, Physics, Chemistry And Biology

Activities and Societies: Throw Ball, Drawing and Essay writing