Ankur Sharma
Medical Devices Assessor/Auditor for EN ISO 13485, MDSAP, CE Mark under EU-MDR 2017/745 and Technical File Reviewer (Non Active Implantable Class III- Cardiovascular Medical Devices)
- Role
- Auditor Assessor for En Iso 13485, Mdsap, Ce Mark -mdd Eu-mdr & Technical File Reviewer at DQS
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
About Ankur Sharma
Senior Medical Devices Quality & Regulatory professional with 26+ years of…
Experience
Auditor Assessor for En Iso 13485, Mdsap, Ce Mark -mdd Eu-mdr & Technical File Reviewer
Oct 2022 — Present · IN
Education
GIC, Mathura
Senior Secondary, Bio group
1990 — 1992
Sikkim Manipal University
MBA (Total Quality Management), TQM
2012 — 2014
GIC, Mathura
Matriculation, Science Group
1990 — 1990
BSA Degree college Mathura
Bachelor of Science - BS, Chemistry
B.S.A. Degree College Mathura
B.SC, Science Bio Group
1992 — 1995
Skills
- Method Validation
- Corrective and Preventive Action (Capa)
- Pms/Pmcf
- Eto Sterilization
- Process Validation
- Iso
- Sop
- Fda
- Tqm
- Iso 14971
- Sterilization
- Regulatory Affairs
- Iso 13485
- Medical Devices
- Capa
- Clean Room Validation
- Auditing
- Medical Writing
- Fda Gmp
- Gxp
- Quality Assurance
- Quality Auditing
- Ce Certification for Medical Devices
- Clean Rooms
- Internal Audit
- Stents
- Iso Standards
- Medical Device Directive
- Design Dossier
- Ce Marking
- Technical Master File
- Clinical Evaluation
- Quality System
- Drug Eluting Stents
- 5s
- Validation
- Standard Operating Procedure (Sop)
- Clean Room
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