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Quality Management System (QMS)

✿ Setting up the whole QMS (ISO 13485:2016)
✿ QMS Plan, Processes, Process Mapping, Implementation & Preparation for Audit
✿ MDSAP Gap Analysis, Implementation and Preparation for Audit
✿ Development of SOPs aiding Regulatory Compliance
✿ Usability Engineering Studies Plan & Report
✿ Risk Management Plan, Analysis & Report & Traceability Matrix
✿ Post Marketing Surveillance Plan & Report





Gap Analysis

✿ Gap Analysis for ISO 13485 – 2003 or 2012 VS 2016
✿ Gap Analysis for MEDDEV 2.7/1 Ver 3.0 VS Ver 4.0
✿ Gap Analysis for Council Directive - MDD 93/42/EEC VS MDR 2017/745
✿ Gap Analysis for Council Directive - IVDD 98/72/EEC VS MDR 2017/745
✿ Gap Analysis for Council Directive – AIMDD 90/385/EEC  VS MDR 2017/745
✿ Gap Analysis for 60601-1 Ed. 3 VS Ed. 3.1
✿ Gap Analysis between any two or multiple quality management systems or SOPs











Internal & External Audits

Internal & External Audits

✿ Have done BSI’s Lead Auditor Training
✿ Have performed Internal Audits
✿ Have been part of several External Audits (As Auditee, Front and Back support)
✿ Have been Audited by Notified Bodies (Unannounced)
✿ Have been Audited by ETL
✿ Create Internal Audit Program, Audit Checklist, Audit Plan, Audit Process, Performing Audit, Audit Report
✿ Certain Segments of Internal Audit, (i-e) Management part to be done by Independent/External Auditors