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Medical Devices & IVDs Technical Consultancy

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      • 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
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      • ISO/IEC 17025:2017
      • ISO 15189:2022
      • ISO/IEC 17021-1:2015
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      • ISO/IEC 17065:2012
      • ISO/IEC 17024:2012
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      • IP ACT- TRADE MARK / PATENT
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      • 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
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      • INDIA- MDR 2017 G.S.R 78 (E)
      • MDR | Regulation (EU) 2017/745)
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