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Medical Devices & IVDs Technical Consultancy

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    • MS Certification Services
      • ISO 13485:2016 & EN ISO 13485:2016 + A11:2021
      • Medical Device Single Audit Program (MDSAP)
      • 21 CFR 820 QSR
      • ICMED 13485 /ICMED 13485 PLUS
      • GHOST-R
      • ISO 9001:2015
      • ISO 14001:2015
      • ISO 45001:2018
    • Accreditation Services
      • ISO/IEC 17025:2017
      • ISO 15189:2022
      • ISO/IEC 17021-1:2015
      • ISO/IEC 17020:2012
      • ISO/IEC 17065:2012
      • ISO/IEC 17024:2012
      • CDSCO Notified Body Approval
    • Regulatory Services
      • INDIA- MDR 2017 G.S.R 78 (E)
      • Ethics Committee Approval – CDSCO/ICMR for Medical Devices
      • AERB Approval for Medical Devices
      • BIS Registration-Medical Devices
      • PC-PNDT Registration Consultancy for Medical Devices
      • IP ACT- TRADE MARK / PATENT
      • CPCP-PWM/ EWM
      • Legal Metrology Registration
      • MDR | Regulation (EU) 2017/745)
      • IVDR | Regulation (EU) 2017/746
      • UK- UKCA
      • USA-USFDA
      • SFDA-MENA
      • Russia / CIS
      • Australia-TGA
      • African Countries
      • Technical Files (EU) MDR745/ IVDR746
      • Risk Assessment for Medical Devices – ISO 14971:2019
      • CER, PMS, PMCF, PSUR, SSCP
      • EUDAMED Registration Services
      • UDI Implementation Guidance
      • GMDN and EMDN codes research
      • Technical File (TF) Review for MDR 2017/745 & IVDR 2017/746
      • Free Sales Certificate (FSC) for Medical Devices & IVDs
      • Notified Body Selection & Application Support
    • Market Access
      • INDIA- MDR 2017 G.S.R 78 (E)
      • MDR | Regulation (EU) 2017/745)
      • IVDR | Regulation (EU) 2017/746
      • UK- UKCA
      • USA-USFDA
      • SFDA-MENA
      • Russia / CIS
      • Australia-TGA
      • African Countries
      • Asean Countries
      • GeM-MSME
      • ZED Certification
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      • CH – REP
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      • Outsource QA
      • Technical Documentation Pack
      • QMS Pack
      • Qualification & Validation Support
      • Validations QMS Software & Software as a Medical Device SaMD
      • Internal Audit Services
      • Supplier Audit Services
      • Third-Party Inspections for MDs & IVDS
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