Ravi Sharma
Lead auditor/ Sr Tech file assessor having 17+ years’ experience in Medical Device. Currently working as medical device Lead auditor/Lead Tech file assessor in Notified body (DQS) for ISO 13485, MDSAP, MDD, EUMDR
- Role
- Lead Auditor Technical File Lead Assessor (Medical Certification) at DQS
- Location
- New Delhi, DL, IN
- LinkedIn followers
- 500 followers
About Ravi Sharma
Regulatory Affairs professional with 16+ years’ experience in Medical Device Industries…
Experience
Lead Auditor Technical File Lead Assessor (Medical Certification)
Dec 2021 — Present · IN
Conducted third party audit for MDD 93/42/EEC, EUMDR 2017/745, MDSAP, ISO 13485,(ANAB, DAKKS, SCC) certification as lead auditor in India and Overseas (USA, Europe) customer.• Medical device Assessment (Technical file) for MDD 93/42/EEC/EUMDR 2017/745 certification as a lead assessor. • Reviewed the QRF (Quotation for request form) and coordinate with client. • Training provided to new auditors regarding the regulation, audits, technical file assessment and help him for their qualification. • Coordinate with DQS Germany regarding the auditors’ qualifications and code approval.• Interviewed, Guide and monitor the new auditors.• Client visits to understand the requirements and for business development• Co-ordination with German office on operations
Education
B.M. Institute of Engineering and Technology
B.TECH
2003 — 2007
Adarsh High School
10th
2000 — 2001
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