Medical Device Regulatory Services
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Regulatory Strategy & Global Market Approvals

Regulatory Strategy & Global Market Approvals

  • Pre-market Notification (510k) Consulting

  • India CDSCO Regulatory Approval Services

  • CDSCO Import Authorization Services

  • CDSCO Factory License Assistance

  • CE Certification under EU MDR

  • UK Market Access via UKCA Certification

  • Russian Market Approval for Devices

  • SFDA Certification for Medical Devices (KSA)

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ISO 13485-Based Quality Management Solutions

ISO 13485-Based Quality Management Solutions

  • FDA 21 CFR PART 820 QUALITY SYSTEM REGULATION

  • MEDICAL DEVICE

  • QMS SOFTWARE (EQMS)

  • ISO 15378:2017

  • CERTIFICATION

  • PRIMARY PACKAGING

  • REGULATORY

  • CONSULTING

  • MDSAP

  • Medical Device QMS Setup & Compliance

  • Technical Feasibility & Strategic Project Reports

  • Turnkey Manufacturing Facility Solutions

  • Regulatory Validation Protocols & Reports

  • Controlled Environment Setup & ISO Guidance

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Medical Device Design Control & Regulatory Documentation

Medical Device Design Control & Regulatory Documentation

  • Drug–Device Integrated Product Services

  • FDA Design Control Compliance (21 CFR 820.30)

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