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USD 60 /hr

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Hire Tarun S.

India

USD 60 /hr

Clinical Evaluation Report preparation and review as per MEDDEV 2.7.1 Rev 4

Profile Summary

Medical device professional with strong background in single use disposables, reusable medical devices(Class I, Class II and Class III) . Broad technical competencies, spanning Regulatory Affairs, Quality, Manufacturing, Project Management, QMS & Product Certifications. Approved Lead Auditor for ISO 13485 & CE Marking (Medical Devices) & EU MDR . • Clinical Evaluation Report preparation and review as per MEDDEV 2.7.1 Rev 4 • Risk Management Report preparation and review as per EN ISO 14971:2012 • PMS Report preparation and review as per MEDDEV 2.12.1 • IFU, Label preparation and review as per EN ISO 15223‐1:2016 and EN 1041:2008+A1:2013 • Review & approval of product labeling & Promotional Material. • Usability Engineering, Creation of Usability Eng. File as per 62366

Subject Matter Expertise

• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 13485
• ☆ Regulatory Affairs
• ☆ Medical Device Regulatory Writing

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing, Newswriting

Research Market Research, User Research, Meta-Research, Gap Analysis, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis, Big Data Analytics

Product Development Stability/Shelf Life Testing

Work Experience

Regulatory Executive.

Romsons Scientific & Surgical Pvt. Ltd

January 2017 - Present

Education

Masters in Biotech

Doon PG College

August 2009 - September 2011

Certifications

• ISO 9001

  MQA CERTIFICATION

  October 2022 - Present

• ISO 14001

  MQA CERTIFICATION

  September 2022 - Present

• ISO 13485:2016 internal Auditor

  Quality Council of India

  June 2021 - Present

• ISO 13485 lead auditor

  BSI India.

  January 2015 - Present