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    • Regulatory Services
      • General Services
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      • CE Marking Services​
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Salvation Global

Regulatory Services

Regulatory Services

General Services

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CDSCO and DCGI Approvals

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CE Marking Services​

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USFDA Approval

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To Know More About Our Services

CONTACT
  • Home
  • About Us
  • Our Services
    • Regulatory Services
      • General Services
      • CDSCO and DCGI Approvals
      • CE Marking Services​
      • USFDA Approval
    • Medical Device – Quality Services
      • Quality System Audits
      • Quality Services
  • Design & Development
  • FAQ’s
  • Blog
  • Contact Us

Regulatory Services – General Services

  • Regulatory Consulting/Strategic services
  • Regulatory Submission Road maps/Regulatory Intelligence Services
  • Regulatory Staffing Services
  • Health Authority interactions/Pre-submission meetings
  • Regulatory/Medical Review of Ad Promo Material
  • Market Access and Regulatory Strategy
  • Regulatory Intelligence
  • Publishing and Submissions
  • Regulatory Labelling
  • Regulatory Artwork Services
  • Regulatory Medical Writing

Regulatory Services – CDSCO & DCGI Approvals

  • CDSCO and DGCI regulatory submissions approvals
  • CDSCO Registration & Licensing of Class A, B, C&D Devices
  • Medical Devices and In-vitro Diagnostic Kits pertaining
  • The site and Product Registration.
  • New Product Approval
  • Import registration of Medical Devices and In-vitro Diagnostic Kits.
  • Free Sale Certificate / GMP Certificate / Market Standing Certificates etc.
  • Export Permissions
  • Establishing a Quality Management System (ISO 13485:2016) as per IMDR 2017
  • Bio-compatibility / Bio-equivalence/ Bio-Availability Studies
  • Dossier development & Technical Files as per IMDR 2017

Regulatory Services – CE Marking​

  • CE Marking
  • EU MDR 2017/745, 2017/746
  • EUDAMED
  • UDI
  • Notified Body
  • Authorized Representative
  • Gap Analysis
  • Technical Documentation
  • PMS
  • PMCF and CER
  • Post Approval Changes Submissions
  • Product Lifecycle Management
  • Global Health Authorities

Regulatory Services – USFDA Approval

  • 510(K) Submissions
  • Pre-Market approval
  • HDE
  • IDE
  • Denovo
  • QSR
  • MDR
  • US Agent
  • Establishment Registration & Device Listing
  • Device Master File (DMF) Submissions
  • Dossier Templates for the U.S
  • Clinical Trial Applications (CTAs) For Global Countries
  • Health Canada Regulatory Global Market Analysis
  • Safety and Pharmacovigilance
  • Regulatory Software and Services
  • Health Authority Interaction
  • Product Registrations and Market Authorizations
  • Lifecycle Management/Post Approval Activities
  • Local on-the-ground Presence
  • Regulatory Centralization

Medical Device – Quality Services

  • Medical Device RA/QA Training
  • QMS Implementation
  • Medical Device QMS Auditing
  • ISO 13485:2016
  • MDSAP Auditing
  • ISO 14971 / Risk Management
  • CAPA & Root Cause Analysis
  • RA/QA Outsourcing

Medical Device – Quality System Audits

  • Quality System Audits For ISO 13485, FDA QSR, MDSAP
  • Pre-assessment & FDA Mock (QSIT) Audits
  • Internal Audits – ISO 13485, FDA QSR, MDSAP, EU MDR & IVDR
  • Auditor Training
  • Supplier Audits
  • Performance-Based Auditing
  • CAPA & Root Cause Analysis
  • Remote Medical Device Audits

Contact Us

Plot No.5/A,
Chitraseema Colony,
Mansoorabad, LB nagar,Rangareddy
Telangana, 500 070.

+91 9059956857
info@salvationglobal.in

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