"Responsible for managing the overall operations and resources of Meditix" 27 years of experience in Medical Device Industry in Regulatory Affairs and Quality Management system. Expert in device regulations across the globe. Strong knowledge in FDA, CE MDR, ISO 13485 and ISO 14971. Handled audits and certified Lead auditor from BSI. Managed the teams in implementing products regulatory standards & Compliance for multiple accounts/ Clients/ Product requirement and review the same as per the target markets product/ government law.

"Responsible for Control and monitor the total quality and regulatory activities in Medical device industries inside and outside of the company." 21 years of significant experience in establishing, monitoring and control of total Quality and Regulatory activities in Medical Device industry. Competent ability in attaining critical third-party audits like Quality Management System certification ISO 13485, MDSAP, USFDA and product qualification audits like CE Mark Certification, UNFPA and LNE-G/Med (NF Mark). Expert in preparing Medical Device Technical Documentation for EU 2017/745 (Medical Device Regulation), Design Dossiers for USFDA 510(K), Common Technical Document for TGA Australia, Common Submission Dossiers for Malaysia and similar approval process across the globe. Proven medical writer for documents like Clinical Evaluation as per Article 61 & Annex XIV Part A of EU 2017/745, MEDDEV 2.7.1/Rev.4, MDCG 2020-5, MDCG 2020-6 requirements, Risk Management Reports as per ISO 14971:2019 requirements, Unique Device Identification (UDI) system as per Article 27 of EU 2017/745, USFDA requirements and Quality Management system Documentation as per ISO 13485 & MDSAP requirements.

"Responsible for all clinical and testing of medical devices in product development and testing environment." 14 years of experience in Product Management, Clinical Research, Usability, testing of medical devices in product development and testing environment. Subject matter expert in preparing, guiding on Clinical Investigation strategy as per ISO 14155, Annex XV of EU 2017/745 requirements, Post market Surveillance & Post market clinical follow-up as per Annex XIV Part B of EU 2017/745, MDCG 2020-7, MEDDEV 2.12/2 rev 2,NB-MED/2.12/Rec1, ISO TR 20416 requirements for the clients. Works as functional Project Manager managing timelines for the project, documentation closure, and submission to notified bodies. Rich experience in report generationClinical Investigation Report (CIR), Periodic Safety Update Report (PSUR), Post Market Surveillance Report (PMSR), Post Market Clinical Follow-up Report (PMCFR) in alignment with relevant stakeholders. Certified ISO 13485 Lead auditor from BSI.

"Responsible for Preparing all kind of technical information for active medical devices" 27 years’ rich experience in Component Engineering, Manufacturing, Assisting Design Engineering, Product Development, Maintenance Operations & Spares Management in Bio-medical, healthcare, Industrial, Power and Process Control Instrumentation. Expert in preparing Technical dossier for active medical devices in relation to CE MDR, MDD, 510(K). Well versed with Product Risk Management and tools as per ISO 14971:2019 and DFMEA, UFMEA, Hazard Analysis. Hands on experience in global medical devices regulations such as FDA 510(k), EU MDR 2017/745, MDD, IEC 60601-1, IEC 62304, 21 CFR Part 11.

"Responsible for clinical evaluation Process for all active and non-active Medical devices and protects it from damage" Dr. Midathala Vijayashree Kumaraswamy BBS, Certified in Evidence Based DiabetesManagement (CCEBDM), Certified in Management of Thyroid disorders(CCMTD) Over 25 years of experience in General medicine, dealt with cases of acute emergencies like poisoning, Status epilepticus, status asthmaticus etc. Handled departments of Pulmonology, Cardiology in Multispeciality hospitals like Apollo Hospitals (Bangalore, Hyderabad),Turaif General Hospital (Saudi Arabia), CRESTA SUPER SPECIALITY CLINIC(Bangalore). Clinical Evaluator for active and non-active medical devices clinical evaluator for more than 100 products.

"Responsible for the assessment and analysis of clinical data to verify the safety and performance and/or effectiveness of the medical device." Dr. Murali Mohan S is a leading and famous Neurosurgeon, practicing in Bangalore. Over 10 years of experience in specializes in brain and Spine surgery.Heads Neurosurgical Services at Sagar Hospitals and synapse Healthcare, Bangalore. Performed over five thousand surgeries and has special interest in complex neurosurgical procedures such as tumor, head and neck junction (CV junction), skull base and spine surgery including scoliosis and deformities. Dr. Murali has performed over five thousand neurological procedures. Areas of interests are Brain tumor junction, Skull base surgeries and spine Surgery. Also, interest in complex spinal deformity surgeries including scoliosis. With the help of his research led to the Development of a novel and indigenous stereotactic apparatus- RADARC, an equipment used in complex neurosurgical procedures involving frame-based navigation. Also performed as a clinical evaluator to evaluate the clinical evaluation report and principle investigator for clinical trials and Post Market Clinical Studies.

"Responsible for providing technical advice on QMS and production Development" Over 24 years of experience in Quality, EMS and OHSAS and regulatory. Widely gives contribution in Quality Management Systems, Regulatory and Document control activity, Preparation of Registration documents as per Regulatory requirements for new product registration and drug licence, Auditing, Reviewing, Confirming that finished goods are tested on time, as per the respective standards and regulatory requirements, Handling of customer complaints and Non-conformances, Monitoring and managing laboratory functions and in process quality control functions, Environmental Management Systems & OHSAS (Health & Safety), Supplier Development, Design and development and training carried out for ISO 9001, ISO 14001, ISO 13485, OHSAS 18001, Product risk management as per ISO 14971, EMS-Aspect identification and impact evaluation, Safety Risk Analysis. Played various role in Quality Assurance.

"Responsible for providing technical advice on medical device biological testing and clean room implementation". Completed Ph.D. in biotechnology. Technical consultant for Class IIa, Class IIb, Class III medical devices and Certified Internal Auditor and lead Auditor for ISO 13485:2016 from BSI. Over 4 years of experience in research field and two years of experience in industrial field. Published literature papers in journal and got Indian patency for “Biosynthesis of Isopropyl myristate”. Trained in developing innovative pedagogy based on the desirable for students, designing new curricula and course based on the vision, focus, objectives and student needs. Hands on experience in seminars/conferences and workshops. Attained considerable knowledge in International Standards such as ISO 13485:2016, ISO 9001:2015, ISO 10993-1:2018, ISO 15883, ISO 14644-1:2015, ISO 17665-1:2006, ISO 17664-1:2021, ISO 11135:2014.