プロフィール詳細

プロジェクトを作成

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Madhu S.に依頼

India

Quality and Regulatory Affairs professional | Expert in CE marking, EU MDR 2017, FDA submissions & lead auditor ISO13485

プロフィール概要

Over 10 years’ experience in Quality and Regulatory Affairs, and technical submissions for a range of medical devices, including Orthopaedics, Surgical Instruments, Disposable Polymeric devices (from I.V Cannula to Haemodializer over a range of 47 devices), TENS devices, dental devices and novel software systems. Prepared and finalised several technical files for CE marking of Class I (Class Im and Class 1s) Class IIa, and IIb devices including all follow-ups and questions from Notified Bodies, including on-site audits from both the FDA and notified bodies (including BSI, DNV and TUV SUD). Responsible for authoring several 510(k) submissions for the FDA, including all relevant attachments and reports (clinical evaluations, FMEA risk management files, Bio-compatibility reporting, process validations, labelling and packaging). Prepared and finalised pre-sub activities with the FDA for novel dental devices in the design phase to establishing the required regulatory pathway. Achieved and maintained registration of products in a range of jurisdictions including India, EU, US, Canada, and UK. Total Expertise in the application of EU MDR 2017/745, ISO 13485 (certified lead Auditor), ISO 14971, FDA 21 CFR Part 820, ISO 10993 standards, ISO 11135, and ISO 11137 standards. Well-versed in the development of Regulatory Files, literature searches, clinical evaluations report as per MEDDEV 2.7.1 rev.4, predicate device comparisons, development of SOP's and other QMS documentation, as well as validations for processes such as sterilization (gamma and EtO), packaging, and Usability Engineering studies.

専門分野

• ★ Medical Device Regulatory Consulting
• ★ European Medical Device Regulation (MDR)
• ★ Product Compliance
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Manufacturing
• ☆ Medical Device Validation
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Regulatory Affairs
• ☆ Medical Device Regulatory Writing
• ☆ Clinical Evaluation Reports (CER)
• ☆ Premarket Notification/510(k) Submission
• ☆ Risk Management

サービス

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Medical Writing, Technical Writing

Research Market Research, Feasibility Study, Fact Checking, Systematic Literature Review, Secondary Data Collection

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis

職務経験

Deputy Manager - Regulatory and Quality Affairs

Technomed Solutions LLP

3月 2020 - 現在

Deputy Manager - Regulatory and Quality Affairs

Vitromed Healthcare

8月 2017 - 12月 2019

Regulatory and Quality Affairs Specialist

Elexes Medical Consulting Pvt. Ltd.

1月 2015 - 9月 2016

学歴

Advanced PG Diploma in CR & Regulatory Affairs (APGDCR-RA)

James Lind Institute, India

1月 2020 - 7月 2023

Post Graduate Diploma in Quality Management

Indira Gandhi National Open University, New Delhi

7月 2017 - 5月 2019

Masters in English Literature

Karnataka State Open University

7月 2009 - 5月 2011

Masters in Science - Biotechnology

University of Mysore

7月 2006 - 5月 2008

Bachelors in Science - Biotechnology

University of Mysore

7月 2003 - 5月 2006

認定資格

• Global Regulatory Strategy for Medical Device

  RAPS

  9月 2025 - 現在

• Internal Auditor for Medical Devices Single Audit Program

  TUV SUD

  11月 2024 - 現在

• ISO 14971: 2019 medical device risk management process training

  BSI India

  12月 2022 - 現在

• BSI Lead Auditor for ISO 13485:2016

  BSI training India

  4月 2018 - 現在