Ashwin Kumar

Expertise Manager - in Vitro Diagnostics @TÜV SÜD

Munich, DE

EMAILS

[email protected]

MOBILE NUMBERS

+91 *********19

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WORK HISTORY

Apr 2024 — Present

Expertise Manager - in Vitro Diagnostics @TÜV SÜD

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Munich, DE

EDUCATION

N/A

BHS First Grade College, Bangalore University

B.Sc Chemistry, Zoology, Microbiology

N/A

Dayananda Sagar Institutions

M.Sc, Microbiology

SKILLS

Quality AuditingElisaGlpGmpBiopharmaceuticalsIso 13485V&VCleaning ValidationQuality System ComplianceStability StudiesMicrobiologyRegulatory AffairsRisk ManagementMedical DevicesCapaQuality AssuranceTechnology Transfer

ABOUT ASHWIN KUMAR

Experience with EU Notified Bodies & In-vitro diagnostics (IVD) industry - Audits as per (EN) ISO 13485, IVDR 2017/746, IVDD 98/79/EC, MDD 93/42/EEC, MDSAP, Taiwan QMS, J-QMS Ordinance, ISO 9001, ISO 15378- Technical Documentation review for IVD devices- Evaluation of Surveillance audit filesSpecialties: QMS Audits, Technical Documentation/ Design Dossier review, Technical Certification, Risk Management, Performance Evaluation, IVD Devices, Medical Devices, Quality Control Testing, Project Management, Design Review, Gap Analysis

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