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    • ISO/IEC 17065:2012
    • ISO/IEC 17024:2012
    • CDSCO Notified Body Approval
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    • MS Certification Services
      • ISO 13485:2016 & EN ISO 13485:2021
      • 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
    • Representative Services
      • Indian Authorized Agent (IAA)
      • EC REP SERVICES
      • UK RP (UK Responsible Person)
      • US AGENT
      • CH – REP
    • Expert Services
      • Facility Designing
      • 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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      • Tailored Trainings
      • Internal Audit Courses
      • Regulatory Trainings
      • Operational Trainings – Awareness & Implementation
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  • Archive from category "Uncategorized"
June 22, 2025
quality control

Medical Device Regulatory Consultancy in Faridabad

Friday, 23 May 2025 by admin

Alpine Quality Consultant provides Consulting services for Medical Device Industry. Our Team of Experts incorporates Healthcare Professionals, Regulatory Compliance Consultants, and Doctors. We give our service in small possible time and cost-effective way. MEDICAL DEVICE REGULATORY CONSULTING SERVICES Alpine Quality Consultants give direction and support to compliances by qualified, experienced, and executive Advisors and Experts

  • Published in Uncategorized
Medical Device Management

CE Mark Certification for Medical Device

Friday, 23 May 2025 by admin

WHAT IS CE MARKING? CE stands for Conformité Européenne, which translates from French to English as ‘European Conformity.CE Mark Certification indicates that a product has been assessed by the manufacturer and deemed to meet EU(European Union’s) safety health and environmental protection requirements. CE mark mandatory conformity marking for regulating the products sold within the European

  • Published in Uncategorized

Blogs

  • quality control

    Medical Device Regulatory Consultancy in Faridabad

    Alpine Quality Consultant provides Consulting s...
  • Medical Device Management

    CE Mark Certification for Medical Device

    WHAT IS CE MARKING? CE stands for Conformité Eu...
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