Dipen Parekh

Responsible for Quality Assurance activities for Standalone Software as well as software embedded in a medical device Risk Management Cybersecurity of SaMD IEC 62304 + IEC 62366 + IEC 82304 compliance Internal Audits Supplier Audits CAPA, NC, FSCA

Regulatory Affairs Manager for IVD registrations and pre-market compliance. Ensuring compliance with IVDD and playing a pivotal role in IVD-R implementation project. Tasks and Responsibilities: Technical Documentation Performance Evaluation Labeling Validation Defining IFU requirements ISO 14971; ISO 13485; IEC 62304; IEC 62366

CE Certification - STED preparation Regulatory Strategy CE & 510k Risk Management Usability Engineering Clinical Evaluation CAPAs, NCs Complaint Handling Medical Device Reporting

Quality Assurance Activities for Class IIa & IIb Products NCs, CAPA, FSCAs Risk Management CE certification Medical Device Reporting Complaint Handling Worldwide

Role: Research Assistant Roles and Responsibilities • Conversion of raw data into DICOM images • Vessel Segmentation of micro-CT images of rats and mice liver. • 3D visualization of the vascular structures such as hepatic vein (HV), portal vein (PV), hepatic artery (HA), bile ducts and vena cava. • Volumetric measurement and comparison of vascular structures of native and post-treatment data. • Basic C++ module modification of already present module library for segmentation and visualization.

• Responsible for ensuring the compliance of QMS • Accountable to the Managing Director for o Maintaining and enhancing current Quality Systems and Standards o Conducting internal audits o Preparing the CE Technical File for Radiant Heat Warmer and Phototherapy Unit. o Functional Analysis, Fault-tree Analysis, FMEA, ISO 14971. o ISO accreditation as per particular standards IEC 60601-2-21 and IEC 60601-2-50.

Role: Biomedical Trainee Work Experience • Gained knowledge on the working principles of medical instruments and their technical aspects via training sessions with the department engineering lead. • Acquired considerable hands-on skills through attending service calls in various departments.

Medical Data Systems, Health Technology Assessment, FMEA, Risk Analysis, Risk Control